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TSP Hip Fracture Plating System device, fixation, proximal femoral, implant The Biomet Hip Frac...

FDA Device Recall #Z-2240-2016 — Class II — June 10, 2016

Recall Summary

Recall Number Z-2240-2016
Classification Class II — Moderate risk
Date Initiated June 10, 2016
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Biomet, Inc.
Location Warsaw, IN
Product Type Devices
Quantity 5458 units

Product Description

TSP Hip Fracture Plating System device, fixation, proximal femoral, implant The Biomet Hip Fracture Plating Systems are indicated for use in the open reduction and internal fixation of a wide variety of fractures of the proximal femur: intracapsular fractures and intertrochanteric fractures. Fracture plates with six or more femoral shaft fixation screw holes are also indicated for subtrochanteric fractures as well as proximal femoral osteotomies

Reason for Recall

The screw may fracture at the junction of the shaft and the head during implantation. The patient may retain a foreign body if the fractured screw cannot be removed. Soft tissue irritation will not occur as the retained portion of the screw is below the surface of the plate. A delay in surgery less than 30 minutes may occur.

Distribution Pattern

Worldwide Distribution - US (Nationwide) Internationally to Australia, The Netherlands, and Japan

Lot / Code Information

All Lots. Part Number / Description: 14-451002 130 DEG 2-HOLE LEFT NECK FX 14-451004 130 DEG 4-HOLE LEFT NECK FX 14-451070 7.5MM TELESCOPE LAG SCR 70MM 14-451075 7.5MM TELESCOPE LAG SCR 75MM 14-451080 7.5MM TELESCOPE LAG SCR 80MM 14-451085 7.5MM TELESCOPE LAG SCR 85MM 14-451090 7.5MM TELESCOPE LAG SCR 90MM 14-451095 7.5MM TELESCOPE LAG SCR 95MM 14-451100 7.5MM TELESCOPE LAG SCR 100MM 14-451102 130 DEG 2-HOLE RIGHT NECK FX 14-451104 130 DEG 4-HOLE RIGHT NECK FX 14-451105 7.5MM TELESCOPE LAG SCR 105MM 14-451110 7.5MM TELESCOPE LAG SCR 110MM 14-451115 7.5MM TELESCOPE LAG SCR 115MM 14-451120 7.5MM TELESCOPE LAG SCR 120MM 14-451125 7.5MM TELESCOPE LAG SCR 125MM 14-451130 7.5MM TELESCOPE LAG SCR 130MM 14-451500 ANGLE GUIDE 130 DEG 14-451502 GUIDE WIRE 3.0MM 14-451503 GUIDE PIN DRIVER 3.0MM 14-451504 TARGETING GUIDE 130 DEG LEFT 14-451505 TARGETING GUIDE 130 DEG RIGHT 14-451509 JIG ATTACHMENT DRIVER 3.5MM 14-451510 NON-LOCK GUIDE SLEEVE 7.5MM 14-451511 LOCKING GUIDE SLEEVE 7.5MM 14-451512 ENTRY TROCAR 7.5 MM 14-451513 DRILL BIT 3.0MM 14-451525 GUIDE WIRE DEPTH GAUGE 3.0MM 14-451526 STEP DRILL CANNULATED 7.5MM 14-451527 STEP DRILL NON-CANN 7.5MM 14-451528 TSP HIP FX TAP 7.5MM 14-451529 HEX DRIVER NECK SLEEVE 5.0MM 14-451530 DRIVER CONNECTOR SHAFT 5.0MM 14-451531 HEX DRIVER NECK SHAFT 3.5MM 14-451532 INSERTER LIMITED COLLAPSE 14-451533 DEPTH GAUGE LIMITED COLLAPSE 14-451535 SCREW GUIDE SLEEVE 4.5MM 14-451536 TROCAR 4.5MM SCREW 14-451537 DRILL GUIDE LOCKING 3.5MM 14-451538 DRILL GUIDE NON-LOCK 3.5MM 14-451539 DRILL BIT 3.5MM 14-451540 SCREW DEPTH GAUGE 4.5MM 14-451541 SCREW DEPTH GAUGE HOOK 4.5MM 14-451542 TSP HIP FX CORTICAL TAP 4.5MM 14-451543 DRIVER 5.0 HEX/3.5 HEXALOBE 14-451544 CONNECTOR SHAFT 4.5MM SCREW 14-451546 T HANDLE W/ HUDSON 14-451550 IMPACTION HANDLE 14-451551 IMPACTION GUIDE PAD 14-451552 IMPACTION PLATE PAD 14-451554 GUIDE WIRE ALIGNMENT ARM 14-451560 GUIDE WIRE PUSHER 2.8MM 14-451561 GUIDE WIRE PLACEMENT TROCAR 14-451562 GUIDE WIRE PLACEMENT SLEEVE 14-451565 SCREW EXTRACTOR 7.5MM SCREW 14-451567 SCREW EXTRACTOR 4.5MM SCREW 14-451568 LAG SCREW REMOVAL TOOL 7.5MM 14-451570 BONE HOOK 14-451571 BALL SPIKE PUSHER 14-451573 REDUCTION TOOL 14-451580 NECK FX INSTRUMENT CASE 14-453005 LIMITED COLLAPSE SLEEVE 5MM 14-453010 LIMITED COLLAPSE SLEEVE 10MM 14-453015 LIMITED COLLAPSE SLEEVE 15MM 14-453020 LIMITED COLLAPSE SLEEVE 20MM 14-454014 4.5MM CORT LOCK SCREW 14MM 14-454016 4.5MM CORT LOCK SCREW 16MM 14-454018 4.5MM CORT LOCK SCREW 18MM 14-454020 4.5MM CORT LOCK SCREW 20MM 14-454022 4.5MM CORT LOCK SCREW 22MM 14-454024 4.5MM CORT LOCK SCREW 24MM 14-454026 4.5MM CORT LOCK SCREW 26MM 14-454028 4.5MM CORT LOCK SCREW 28MM 14-454030 4.5MM CORT LOCK SCREW 30MM 14-454032 4.5MM CORT LOCK SCREW 32MM 14-454034 4.5MM CORT LOCK SCREW 34MM 14-454036 4.5MM CORT LOCK SCREW 36MM 14-454038 4.5MM CORT LOCK SCREW 38MM 14-454040 4.5MM CORT LOCK SCREW 40MM 14-454042 4.5MM CORT LOCK SCREW 42MM 14-454044 4.5MM CORT LOCK SCREW 44MM 14-454046 4.5MM CORT LOCK SCREW 46MM 14-454048 4.5MM CORT LOCK SCREW 48MM 14-454050 4.5MM CORT LOCK SCREW 50MM 14-454052 4.5MM CORT LOCK SCREW 52MM 14-454054 4.5MM CORT LOCK SCREW 54MM 14-454056 4.5MM CORT LOCK SCREW 56MM 14-454058 4.5MM CORT LOCK SCREW 58MM 14-454060 4.5MM CORT LOCK SCREW 60MM 14-454065 4.5MM CORT LOCK SCREW 65MM 14-454070 4.5MM CORT LOCK SCREW 70MM 14-454075 4.5MM CORT LOCK SCREW 75MM 14-454080 4.5MM CORT LOCK SCREW 80MM 14-454085 4.5MM CORT LOCK SCREW 85MM 14-454090 4.5MM CORT LOCK SCREW 90MM 14-454095 4.5MM CORT LOCK SCREW 95MM 14-455014 4.5MM CORT NON-LOCK SCREW 44MM 14-455016 4.5MM CORT NON-LOCK SCREW 16MM 14-455018 4.5MM CORT NON-LOCK SCREW 18MM 14-455020 4.5MM CORT NON-LOCK SCREW 20MM 14-455022 4.5MM CORT NON-LOCK SCREW 22MM 14-455024 4.5MM CORT NON-LOCK SCREW 24MM 14-455026 4.5MM CORT NON-LOCK SCREW 26MM 14-455028 4.5MM CORT NON-LOCK SCREW 28MM 14-455030 4.5MM CORT NON-LOCK SCREW 30MM 14-455032 4.5MM CORT NON-LOCK SCREW 32MM 14-455034 4.5MM CORT NON-LOCK SCREW 34MM 14-455036 4.5MM CORT NON-LOCK SCREW 36MM 14-455038 4.5MM CORT NON-LOCK SCREW 38MM 14-455040 4.5MM CORT NON-LOCK SCREW 40MM 14-455042 4.5MM CORT NON-LOCK SCREW 42MM 14-455044 4.5MM CORT NON-LOCK SCREW 44MM 14-455046 4.5MM CORT NON-LOCK SCREW 46MM 14-455048 4.5MM CORT NON-LOCK SCREW 48MM 14-455050 4.5MM CORT NON-LOCK SCREW 50MM 14-455052 4.5MM CORT NON-LOCK SCREW 52MM 14-455054 4.5MM CORT NON-LOCK SCREW 54MM 14-455056 4.5MM CORT NON-LOCK SCREW 56MM 14-455058 4.5MM CORT NON-LOCK SCREW 58MM 14-455060 4.5MM CORT NON-LOCK SCREW 60MM 14-455065 4.5MM CORT NON-LOCK SCREW 65MM 14-455070 4.5MM CORT NON-LOCK SCREW 70MM 14-455075 4.5MM CORT NON-LOCK SCREW 75MM 14-455080 4.5MM CORT NON-LOCK SCREW 80MM 14-455085 4.5MM CORT NON-LOCK SCREW 85MM 14-455090 4.5MM CORT NON-LOCK SCREW 90MM 14-455095 4.5MM CORT NON-LOCK SCREW 95MM

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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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