rHead Lateral Stem, Size 1, Do Not Reuse, Sterile. Intended for replacement of the proximal end o...
FDA Device Recall #Z-2426-2015 — Class II — June 24, 2015
Recall Summary
| Recall Number | Z-2426-2015 |
| Classification | Class II — Moderate risk |
| Date Initiated | June 24, 2015 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Stryker Howmedica Osteonics Corp. |
| Location | Mahwah, NJ |
| Product Type | Devices |
| Quantity | 16992 total |
Product Description
rHead Lateral Stem, Size 1, Do Not Reuse, Sterile. Intended for replacement of the proximal end of the radius.
Reason for Recall
Stryker is recalling rHead, uHead, Sigmoid Notch, Remotion, Radio Capitellum because packaging integrity (sterile barrier) of the packaging type KIT I may potentially be compromised by transportation.
Distribution Pattern
Worldwide Distribution.
Lot / Code Information
Part Number: 310-0000 (Lateral Assembly, Radial Implant, Size 1) Lot #'s 22288301, 22890701, 23424401, 23916901, 19058-S2, 19452-S2, 19661-S2, 19662-S2, 19712-S2, 19736-S2 and 19841-S2; Part Number: 310-0001 (Lateral Assembly, Radial Implant, Size 2) Lot #'s 22629201, 22890801, 23424501, 23917001, 19453-S2, 19737-S2, 19765-S2, 19766-S2 and 19793-S2; Part Number:310-0002 (Lateral Assembly, Radial Stem Implant, Size 3) Lot #'s 22288401, 22629301, 23198901, 23434601, 23917101, 19678-S2, 19767-S2, 19768-S2, 19794-S2 and 19842-S2; Part Number: 310-0003 (Lateral Assembly, Radial Implant, Size 4) Lot #'s 22288501, 23199001, 23424701, 23917201, 19068-S2, 19679-S2, 19713-S2, 19738-S2, 19795-S2 and 19843-S2; Part Number: 310-0004 (Lat Assembly, Rad Stem Implant, Collar 6mm, Size1) Lot #'s 22288601, 23424801, 19057-S2, 19067-S2, 19454-S2, 19739-S2, 19796-S2 and 19844-S2; Part Number: 310-0005 (Lat Assembly, Rad Stem Implant, Collar 6mm, Size 2) Lot #'s 23424901, 23917301, 19063-S2, 19124-S2, 19455-S2, 19714-S2, 19740-S2 and 19797-S2; Part Number: 310-0006 (Lat Assembly, Rad Stem Implant, Collar 6mm, size 3) Lot #'s 23199101, 23425001, 19059-S2, 19680-S2, 19741-S2, 19798-S2 and 19845-S2; Part Number: 310-0007 (Lat Assembly, Rad Stem Implant, Collar 6mm, size 4) Lot #"s 22890901, 2345101, 19060-S2, 19125-S2 and 19457-S2; Part Number: 310-0008 (Lateral Assembly, Radial Head Implant, Size 2) Lot #'s 22288701, 22629401, 22891001, 23199201, 23425201 and 23917401; Part Number:(Lateral Assembly, Radial Head Implant, Size 3) Lot #'s 15886, 22288801, 22629501, 22891101, 23199301, 23425301, 23917501 and 23917502; Part Number: 310-0010 (Lat Assembly, Rad Stem Head Implant, Size 4) Lot #'s 15887, 23199401, 23425401, 23917601 and 19458-S2; Part Number: 310-0011 (Lateral Assembly, Radial Head Impl Assembly, Size 2) Lot #'s 16708, 16709, 22629601, 22891201 and 23425501; Part Number: 310-0012 (Lateral Assembly, Radial Head Impl Assembly, Size 3) Lot #'s 16710, 16711, 22629701, 22891301 and 23425601; Part Number: 310-0013 (Lateral Assembly, Radial Head Impl Assembly, Size 4) Lot #'s 16712 and 23425701; Part Number: 310-2010 (rHead Stem Implant Plasma Coated, Size1) Lot #'s 22552401, 19693-S2, 19742-S2 and 19799-S2; Part Number: 310-2011 (rHead Stem Implant Plasma Coated, Size 2) Lot #'s 22552501, 19694-S2 and 19743-S2; Part Number: 310-2012 (rHead Stem Implant Plasma Coated, Size 3) Lot #'s 22552601, 19070-S2, 19695-S2, 19744-S2 and 19800-S2; Part Number: 310-2013 (rHead Stem Implant Plasma Coated, Size 4) Lot #'s 22552701, 19696-S2 and 19745-S2; Part Number: 310-2014 (rHead Stem Implant 6mm Collar, Size 1) Lot #'s 22552801, 22552802, 19697-S2, 19698-S2 and 19746-S2; Part Number: 310-2015 (rHead Stem Implant 6mm Collar, Size 2) Lot #'s 22552901, 19699-S2, 19747-S2 and 19915-S2; Part Number: 310-2016 (rHead Stem Implant 6mm Collar, Size 3) Lot #'s 22553001, 19700-S2 and 19748-S2; Part Number: 310-2017 (rHead Stem Implant 6mm Collar, Size 4) Lot #22553101; Part Number: 310-2018 (rHead Recon Stem Implant Plasma Coated, Size 1) Lot #'s 22553201, 22889801, 19701-S2, 19749-S2 and 19801-S2; Part Number: 310-2019 (rHead Recon Stem Implant Plasma Coated, Size 2) Lot #'s 22553301, 22889901, 19702-S2, 19750-S2, 19916-S2 and 19975-S2; Part Number: 310-2020 (rHead Recon Stem Implant Plasma Coated, Size 3) Lot #'s 22553401, 22890001, 19703-S2, 19751-S2, 19802-S2 and 19976-S2; Part Number: 310-2021 (rhead Recon Stem Implant Plasma Coated, Size 4) Lot #'s 22553501, 22890101, 197076-S2, 19704-S2, 19752-S2, 19917-S2 and 19977-S2; Part Number: 310-2022 (rHead Recon Stem Implant 6mm Collar, Size 1) Lot #'s 22553601, 22890201, 197501-S2 and 19753-S2; Part Number: 310-2023 (rHead Recon Stem Implant 6mm Collar, Size 2) Lot #'s 22553701, 22890301, 19706-S2 and 19754-S2; Part Number: 310-2024 (rHead Recon Stem Implant 6mm Collar, Size 3) Lot #'s 22553801, 22890401, 19075-S2, 19707-S2 and 19755-S2; Part Number: 310-2025 (rHead Recon Stem Implant 6mm Collar, Size 4) Lot #'s22553901, 22890501 and 19071-S2; Part Number: 410-0100 (rHead Standard Extended Stem 6mm Collar, Size 1) Lot #'s 18527, 18724, 19681-S2 and 19715-S2; Part Number: 410-0101 (rHead Standard Extended Stem 6mm Collar, Size 2) Lot #'s 18528, 18725, 19682-S2 and 19756-S2; Part Number: 410-0102 (rHead Standard Extended Stem 6mm Collar, Size 3) Lot #'s 18529, 18726, 19663-S2 and 19757-S2; Part Number: 410-0103 (rHead Standard Extended Stem 6mm Collar, Size 4) Lot #'s 18530, 18727, 19683-S2 and 19758-S2; Part Number: RCN-S160 (rHead Recon Stem Implant Non-Coated, Size 1) Lot #'s 18370, 18371, 18388, 18569, 18698, 18718 22614101, 22849001, 23068201, 19102-S2, 19103-S2, 19104-S2, 19717-S2, 19804-S2 and 19920-S2; Part Number: RCN-S260 (rHead Recon Stem Implant Non-Coated, Size 2) Lot #'s 18372, 18373, 18699, 18719, 18840, 22614301, 22849201, 23068401, 19105-S2, 19106-S2, 19107-S2, 19773-S2, 19851-S2 and 19984-S2; Part Number: RCN-S360 (rHead Recon Stem Implant Non-Coated, Size 3) Lot #'s 18570, 18571, 18700, 18701, 18702, 18755, 18841, 1884222298301, 22298302, 22849401, 23479801, 19108-S2, 19723-S2, 19807-S2, 19854-S2, 19986-S2 and R23479801; Part Number: RCN-S460 (rHead Recon Stem Implant Non-Coated, Size 4) Lot #'s18572, 18703, 18704, 18756, 18843, 18844, 22298401, 22614601, 22849601, 19109-S2 and 19110-S2; Part Number: RHA-S160 (rhead Radial Implant 6mm Collar, Size 1) Lot #''s 18375, 18386, 18501, 18707, 18708, 18848, 18849, 18850, 18851, 18852, 22613101, 22850101, 23069101, 19113-S2, 19114-S2, 19115-S2, 19779-S2 and 19809-S2; Part Number: RHA-S260 (rhead Radial Implant 6mm Collar, Size 2) Lot #'s 18376, 18384, 18385, 18502, 18575, 18709, 18720, 18853, 18854, 22613301, 22850301, 23069301, 19116-S2, 19117-S2 and 19782-S2; Part Number: RHA-S360 (rhead Radial Implant 6mm Collar, Size 3) Lot #'s 18377,18383, 18503, 18710, 18711, 18856, 18857, 18858, 18859, 22613501, 22850501, 19118-S2, 19119-S2, 19730-S2 and 19813-S2; Part Number: RHA-S460 (rhead Radial Implant 6mm Collar, Size 4) Lot #'s 18379, 18382, 18504, 18576, 18712, 18713, 18860, 18861, 18862, 22613701, 22850701, 19120-S2 and 19121-S2
Other Recalls from Stryker Howmedica Osteonics Corp.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2160-2017 | Class II | Hoffmann LRF Safety Clip (Bone Transport Strut)... | Apr 26, 2017 |
| Z-1020-2017 | Class II | Reunion TSA Peg Alignment Sound Catalog #5901... | Dec 2, 2016 |
| Z-0880-2017 | Class II | GAM Kirschner Wire, Sterile R, T2 K-Wire, Steri... | Nov 9, 2016 |
| Z-0378-2017 | Class II | LFIT Anatomic V40 Femoral Head, Low Friction Io... | Aug 29, 2016 |
| Z-0060-2017 | Class II | Stryker Orthopaedics Universal Acetabular Cup P... | Aug 18, 2016 |
Frequently Asked Questions
Sterility recalls for medical devices vary in severity. If you have already had a procedure using a potentially non-sterile device, contact your healthcare provider immediately — you may need monitoring for signs of infection. Symptoms to watch for include fever, redness or swelling at the surgical site, unusual pain, or discharge. For devices that have not yet been used, they should be quarantined and returned to the manufacturer per the recall notice. Non-sterile implants can cause serious infections; early detection and treatment are critical.
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.