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NUVASIVE PRECICE UNYTE System (Humerus and Tibia): PRECICE Trauma Nail System/PRECICE Unyte-Hu...

FDA Device Recall #Z-1350-2021 — Class II — February 12, 2021

Recall Summary

Recall Number Z-1350-2021
Classification Class II — Moderate risk
Date Initiated February 12, 2021
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Nuvasive Specialized Orthopedics Inc
Location Aliso Viejo, CA
Product Type Devices
Quantity 229 units

Product Description

NUVASIVE PRECICE UNYTE System (Humerus and Tibia): PRECICE Trauma Nail System/PRECICE Unyte-Humerus Orthopedic trauma intramedullary rod, humerus, 8.5 mm diameter, 165 mm length; Orthopedic trauma intramedullary rod, humerus, 8.5 mm diameter, 180 mm length; Orthopedic trauma intramedullary rod, humerus, 8.5 mm diameter, 195 mm length; Orthopedic trauma intramedullary rod, humerus, 8.5 mm diameter, 210 mm length; Orthopedic trauma intramedullary rod, humerus, 8.5 mm diameter, 225 mm length; Orthopedic trauma intramedullary rod, humerus, 8.5 mm diameter, 240 mm length; Orthopedic trauma intramedullary rod, humerus, 8.5 mm diameter, 255 mm length; Orthopedic trauma intramedullary rod, humerus, 8.5 mm diameter, 270 mm length; Orthopedic trauma intramedullary rod, humerus, 8.5 mm diameter, 285 mm length; Orthopedic trauma intramedullary rod, humerus, 8.5 mm diameter, 300 mm length; End Cap for PRECICE Trauma Intramedullary Nail System Implant (humeral nail, 0mm); End Cap for PRECICE Trauma Intramedullary Nail System Implant (humeral nail, 2mm); End Cap for PRECICE Trauma Intramedullary Nail System Implant (humeral nail, 5mm); End Cap for PRECICE Trauma Intramedullary Nail System Implant (humeral nail, 10mm); End Cap for PRECICE Trauma Intramedullary Nail System Implant (humeral nail, 15mm); End Cap for PRECICE Trauma Intramedullary Nail System Implant (humeral nail, 0mm); End Cap for PRECICE Trauma Intramedullary Nail System Implant (humeral nail, 2mm); End Cap for PRECICE Trauma Intramedullary Nail System Implant (humeral nail, 5mm); End Cap for PRECICE Trauma Intramedullary Nail System Implant (humeral nail, 10mm); End Cap for PRECICE Trauma Intramedullary Nail System Implant (humeral nail, 15mm); 3.5 mm Locking Screw, 20 mm Length; 3.5 mm Locking Screw 25 mm Length; 3.5 mm Locking Screw 30 mm Length; 3.5 mm Locking Screw 35 mm Length; 3.5 mm Locking Screw 40 mm Length; 3.5 mm Locking Screw 45 mm Length; 3.5 mm Locking Screw 50 mm Length; 3.5 mm Locking Screw 55 mm Length; 3.5 mm Locking Screw 60 mm Length; Locking Screw, 3.5x65mm; Locking Screw, 3.5x70mm; Locking Screw, 3.5x75mm; 5.0 mm Locking Screw 20 mm Length; 5.0 mm Locking Screw 25 mm Length; 5.0 mm Locking Screw 30 mm Length; 5.0 mm Locking Screw 35 mm Length; 5.0 mm Locking Screw 40 mm Length; 5.0 mm Locking Screw 45 mm Length; 5.0 mm Locking Screw 50 mm Length; 5.0 mm Locking Screw 55 mm Length; 5.0 mm Locking Screw 60 mm Length; 5.0 mm Locking Screw 65 mm Length; 5.0 mm Locking Screw 70 mm Length; 5.0 mm Locking Screw 75 mm Length; 5.0 mm Locking Screw 20 mm Length; 5.0 mm Locking Screw 25 mm Length; 5.0 mm Locking Screw 30 mm Length; 5.0 mm Locking Screw 35 mm Length; 5.0 mm Locking Screw 40 mm Length; 5.0 mm Locking Screw 45 mm Length; 5.0 mm Locking Screw 50 mm Length; 5.0 mm Locking Screw 55 mm Length; 5.0 mm Locking Screw 60 mm Length; 5.0 mm Locking Screw 65 mm Length; 5.0 mm Locking Screw 70 mm Length; 5.0 mm Locking Screw 75 mm Length; 5.0 mm X 80 mm Locking Screw, Peg; 5.0 mm X 85 mm Locking Screw, Peg; 5.0 mm X 90 mm Locking Screw, Peg; 5.0 mm X 95 mm Locking Screw, Peg; 5.0 mm X 100 mm Locking Screw, Peg; PRECICE Trauma Nail System/Precice Unyte-Tibia Orthopedic trauma intramedullary rod, antegrade tibia 10 degree bend, 11.5 mm diameter, 240 mm length; Orthopedic trauma intramedullary rod, antegrade tibia 10 degree bend, 11.5 mm diameter, 255 mm length; Orthopedic trauma intramedullary rod, antegrade tibia 10 degree bend, 11.5 mm diameter, 270 mm length; Orthopedic trauma intramedullary rod, antegrade tibia 10 degree bend, 11.5 mm diameter, 285 mm length; Orthopedic trauma intramedullary rod, antegrade tibia 10 degree bend, 11.5 mm diameter, 300 mm length; Orthopedic trauma intramedullary rod, antegrade tibia 10 degree bend, 11.5 mm diameter, 315 mm length; Orthopedic trauma intramedullary rod, antegrade tibia 10 degree bend, 11.5 mm diameter, 330 mm length; Orthopedic trauma intra

Reason for Recall

Due to not having the full complement of biological assessments for all potential patients and as a result the devices are not indicated for use in individuals under the age of 18 years old.

Distribution Pattern

Worldwide distribution, including U.S. Nationwide.

Lot / Code Information

All Lots manufactured between April 2015 to February 2021. PRECICE Unyte Product Codes (for Humerus): Trauma intramedullary rod, humerus, 8.5 mm diameter: CDH8.5-20L165; CDH8.5-20L180; CDH8.5-30L195; CDH8.5-50L210; CDH8.5-50M225; CDH8.5-50M240; CDH8.5-80M255; CDH8.5-80M270; CDH8.5-80M285; CDH8.5-80M300; end cap for trauma intramedullary humeral nail: HEC1-000; HEC2-000; HEC3-000; HEC4-000; HEC5-000; Locking screws: LSB3-020; LSB3-025; LSB3-030; LSB3-035; LSB3-040; LSB3-045; LSB3-050; LSB3-055; LSB3-060; LSB3-065; LSB3-070; LSB3-075; LSB5-020; LSB5-025; LSB5-030; LSB5-035; LSB5-040; LSB5-045; LSB5-050; LSB5-055; LSB5-060; LSB5-065; LSB5-070; LSB5-075; LSC5-020; LSC5-025; LSC5-030; LSC5-035; LSC5-040; LSC5-045; LSC5-050; LSC5-055; LSC5-060; LSC5-065; LSC5-070; LSC5-075; LSC5-080; LSC5-085; LSC5-090; LSC5-095; LSC5-100. GTIN Number (for Humerus): 00812258022730; 00812258022747; 00812258022754; 00812258022761; 00812258022778; 00812258022785; 00812258022792; 00812258022808; 00812258022815; 00812258022822; 00812258028121; 00812258028138; 00812258028145; 00812258028152; 00812258028169; 00812258021337; 00812258021344; 00812258021351; 00812258021368; 00812258021375; 00812258021382; 00812258021399; 00812258021405; 00812258021412; 00887517936233; 00887517936240; 00887517936257; 00856719002886; 00856719002893; 00856719002909; 00856719002916; 00856719002923; 00856719002930; 00856719002947; 00856719002954; 00856719002961; 00856719002978; 00856719002985; 00856719002992; 00812258021511; 00812258021528; 00812258021535; 00812258021542; 00812258021559; 00812258021566; 00812258021573; 00812258021580; 00812258021597; 00812258021603; 00812258021610; 00812258021627; 00887517001030; 00887517001047; 00887517001054; 00887517001061; 00887517001078; Precice Unyte Product Codes (for Tibia): trauma intramedullary rod, 11.5 mm diameter: CDT11.5-30T240; CDT11.5-30T255; CDT11.5-30T270; CDT11.5-30T285; CDT11.5-30T300; CDT11.5-30T315; CDT11.5-30T330; CDT11.5-30T345; CDT11.5-30T360; CDT11.5-30T375; CDT11.5C-30T240; CDT11.5C-30T255; CDT11.5C-30T270; CDT11.5C-30T285; CDT11.5C-30T300; CDT11.5C-30T315; CDT11.5C-30T330; CDT11.5C-30T345; CDT11.5C-30T360; CDT11.5C-30T375; trauma intramedullary rod, 12.5 mm diameter: CDT12.5-30T240; CDT12.5-30T255; CDT12.5-30T270; CDT12.5-30T285; CDT12.5-30T300; CDT12.5-30T315; CDT12.5-30T330; CDT12.5-30T345; CDT12.5-30T360; CDT12.5-30T375; CDT12.5C-30T240; CDT12.5C-30T255; CDT12.5C-30T270; CDT12.5C-30T285; CDT12.5C-30T300; CDT12.5C-30T315; CDT12.5C-30T330; CDT12.5C-30T345; CDT12.5C-30T360; CDT12.5C-30T375; end cap for trauma intramedullary nail: TEC1-000; TEC1-005; TEC1-010; TEC1-015; TEC1-020; Locking screws: TSA4.5-020; TSA4.5-025; TSA4.5-030; TSA4.5-035; TSA4.5-040; TSA4.5-045; TSA4.5-050; TSA4.5-055; TSA4.5-060; TSA4.5-065; TSA4.5-070; TSA4.5-075; TSA4-020; TSA4-022.5; TSA4-025; TSA4-027.5; TSA4-030; TSA4-032.5; TSA4-035; TSA4-037.5; TSA4-040; TSA4-042.5; TSA4-045; TSA4-047.5; TSA4-050; TSA4-055; TSA4-060; TSA4-065; TSA4-070; TSA4-075; TSA4-080; TSA4-085; TSA4-090; TSA4-095; TSA4-100; TSA4-100; TSA5-020; TSA5-020; TSA5-022.5; TSA5-022.5; TSA5-025; TSA5-025; TSA5-027.5; TSA5-027.5; TSA5-030; TSA5-030; TSA5-032.5; TSA5-032.5; TSA5-035; TSA5-035; TSA5-037.5; TSA5-037.5; TSA5-040; TSA5-040; TSA5-042.5; TSA5-042.5; TSA5-045; TSA5-045; TSA5-047.5; TSA5-047.5; TSA5-050; TSA5-050; TSA5-052.5; TSA5-055; TSA5-055; TSA5-057.5; TSA5-060; TSA5-060; TSA5-062.5; TSA5-065; TSA5-065; TSA5-067.5; TSA5-070; TSA5-070; TSA5-072.5; TSA5-075; TSA5-075; TSA5-080; TSA5-080; TSA5-085; TSA5-085; TSA5-090; TSA5-090; TSA5-095; TSA5-095; TSA5-100; TSA5-100; TSA5-105; TSA5-105; TSA5-110; TSA5-110. GTIN Number (for Tibia): 00812258027322; 00812258027339; 00812258027346; 00812258027353; 00812258027360; 00812258027377; 00812258027384; 00812258027391; 00812258027407; 00812258027414; 00812258027421; 00812258027438; 00812258027445; 00812258027452; 00812258027469; 00812258027476; 00812258027483; 00812258027490; 00812258027506; 00812258027513; 00812258027520; 00812258027537; 00812258027544; 00812258027551; 00812258027568; 00812258027575; 00812258027582; 00812258027599; 00812258027605; 00812258027612; 00812258027629; 00812258027636; 00812258027643; 00812258027650; 00812258027667; 00812258027674; 00812258027681; 00812258027698; 00812258027704; 00812258027711; 00812258028039; 00812258028046; 00812258028053; 00812258028060; 00812258028077; 00887517936011; 00887517936028; 00887517936035; 00887517936042; 00887517936059; 00887517936066; 00887517936073; 00887517936080; 00887517936097; 00887517936202; 00887517936219; 00887517936226; 00887517000033; 00887517000040; 00887517000057; 00887517000064; 00887517000071; 00887517000088; 00887517000095; 00887517000101; 00887517000118; 00887517000125; 00887517000132; 00887517000149; 00887517000156; 00887517000163; 00887517000170; 00887517000187; 00887517000194; 00887517000200; 00887517000217; 00887517000224; 00887517000231; 00887517000248; 00887517000255; 00887517000255; 00812258027728; 00887517000262; 00812258027735; 00887517000279; 00812258027742; 00887517000286; 00812258027759; 00887517000293; 00812258027766; 00887517000309; 00812258027773; 00887517000316; 00812258027780; 00887517000323; 00812258027797; 00887517000330; 00812258027803; 00887517000347; 00812258027810; 00887517000354; 00812258027827; 00887517000361; 00812258027834; 00887517000378; 00812258027841; 00887517000385; 00812258027858; 00812258027865; 00887517000392; 00812258027872; 00812258027889; 00887517000408; 00812258027896; 00812258027902; 00887517000415; 00812258027919; 00812258027926; 00887517000422; 00812258027933; 00812258027940; 00887517000439; 00812258027957; 00887517000446; 00812258027964; 00887517000453; 00812258027971; 00887517000460; 00812258027988; 00887517000477; 00812258027995; 00887517000484; 00812258028008; 00812258028008; 00812258028015; 00812258028015; Precice Unyte Product Codes (covers both Humerus and Tibia): trauma intramedullary rod, 10.7 mm diameter: T10.7-50A205; T10.7-50A225; T10.7-50A240; T10.7-50B205; T10.7-50B225; T10.7-50B240; T10.7-50C205; T10.7-50C225; T10.7-50C240; T10.7-50D205; T10.7-50D225; T10.7-50D240; T10.7-50E205; T10.7-50E225; T10.7-50E240; T10.7-80A255; T10.7-80A285; T10.7-80A315; T10.7-80A345; T10.7-80A375; T10.7-80B255; T10.7-80B285; T10.7-80B315; T10.7-80B345; T10.7-80B375; T10.7-80C255; T10.7-80C285; T10.7-80C315; T10.7-80C345; T10.7-80C375; T10.7-80D255; T10.7-80D285; T10.7-80D315; T10.7-80D345; T10.7-80D375; T10.7-80E255; T10.7-80E285; T10.7-80E315; T10.7-80E345; T10.7-80E375; trauma intramedullary rod, 12.5 mm diameter: T12.5-50A205; T12.5-50A225; T12.5-50A240; T12.5-50B205; T12.5-50B225; T12.5-50B240; T12.5-50C205; T12.5-50C225; T12.5-50C240; T12.5-50D205; T12.5-50D225; T12.5-50D240; T12.5-50E205; T12.5-50E225; T12.5-50E240; T12.5-80A255; T12.5-80A285; T12.5-80A315; T12.5-80A345; T12.5-80A375; T12.5-80B255; T12.5-80B285; T12.5-80B315; T12.5-80B345; T12.5-80B375; T12.5-80C255; T12.5-80C285; T12.5-80C315; T12.5-80C345; T12.5-80C375; T12.5-80D255; T12.5-80D285; T12.5-80D315; T12.5-80D345; T12.5-80D375; T12.5-80E255; T12.5-80E285; T12.5-80E315; T12.5-80E345; T12.5-80E375; trauma intramedullary rod, 8.5 mm diameter: T8.5-50A205; T8.5-50A225; T8.5-50A240; T8.5-50B205; T8.5-50B225; T8.5-50B240; T8.5-50C205; T8.5-50C225; T8.5-50C240; T8.5-50D205; T8.5-50D225; T8.5-50D240; T8.5-50E205; T8.5-50E225; T8.5-50E240; T8.5-80A255; T8.5-80A285; T8.5-80A315; T8.5-80A345; T8.5-80A375; T8.5-80B255; T8.5-80B285; T8.5-80B315; T8.5-80B345; T8.5-80B375; T8.5-80C255; T8.5-80C285; T8.5-80C315; T8.5-80C345; T8.5-80C375; T8.5-80D255; T8.5-80D285; T8.5-80D315; T8.5-80D345; T8.5-80D375; T8.5-80E255; T8.5-80E285; T8.5-80E315; T8.5-80E345; T8.5-80E375; GTIN Number (covers both Humerus and Tibia): 00812258023836; 00812258023843; 00812258023850; 00812258023119; 00812258023126; 00812258023133; 00812258023591; 00812258023607; 00812258023614; 00812258023355; 00812258023362; 00812258023379; 00812258024079; 00812258024086; 00812258024093; 00812258023867; 00812258023874; 00812258023881; 00812258023898; 00812258023904; 00812258023140; 00812258023157; 00812258023164; 00812258023171; 00812258023188; 00812258023621; 00812258023638; 00812258023645; 00812258023652; 00812258023669; 00812258023386; 00812258023393; 00812258023409; 00812258023416; 00812258023423; 00812258024109; 00812258024116; 00812258024123; 00812258024130; 00812258024147; 00812258023911; 00812258023928; 00812258023935; 00812258023195; 00812258023201; 00812258023218; 00812258023676; 00812258023683; 00812258023690; 00812258023430; 00812258023447; 00812258023454; 00812258024154; 00812258024161; 00812258024178; 00812258023942; 00812258023959; 00812258023966; 00812258023973; 00812258023980; 00812258023225; 00812258023232; 00812258023249; 00812258023256; 00812258023263; 00812258023706; 00812258023713; 00812258023720; 00812258023737; 00812258023744; 00812258023461; 00812258023478; 00812258023485; 00812258023492; 00812258023508; 00812258024185; 00812258024192; 00812258024208; 00812258024215; 00812258024222; 00812258023751; 00812258023768; 00812258023775; 00812258023034; 00812258023041; 00812258023058; 00812258023515; 00812258023522; 00812258023539; 00812258023270; 00812258023287; 00812258023294; 00812258023997; 00812258024000; 00812258024017; 00812258023782; 00812258023799; 00812258023805; 00812258023812; 00812258023829; 00812258023065; 00812258023072; 00812258023089; 00812258023096; 00812258023102; 00812258023546; 00812258023553; 00812258023560; 00812258023577; 00812258023584; 00812258023300; 00812258023317; 00812258023324; 00812258023331; 00812258023348; 00812258024024; 00812258024031; 00812258024048; 00812258024055; 00812258024062;

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Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

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