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Synthes Cranial Flap Tube Clamp and Crimping Device Product Usage: The Synthes Cranial Flap ...

FDA Device Recall #Z-2811-2015 — Class II — August 31, 2015

Recall Summary

Recall Number Z-2811-2015
Classification Class II — Moderate risk
Date Initiated August 31, 2015
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Synthes (USA) Products LLC
Location West Chester, PA
Product Type Devices
Quantity 105882

Product Description

Synthes Cranial Flap Tube Clamp and Crimping Device Product Usage: The Synthes Cranial Flap Tube Clamp System is intended to reattach a cranial bone flap to the surrounding cranium after a craniotomy procedure.

Reason for Recall

The Synthes Cranial Flap Tube Clamp and Crimping Device for Cranial Tube Clamp had been labeled MR Safe although they do not have the testing protocols currently required to designate them as MR Safe.

Distribution Pattern

US Nationwide and internationally, including Canada.

Lot / Code Information

Part Number 329.315 460.001 460.001.01S 460.002 460.002.01S 460.003 460.003.01S 460.008 460.008.01S 460.009 460.009.01S 460.010 460.010.01S 460.100 460.100.01S 460.107 460.107.01S with Lot Numbers 4146716, 4154144, 4206682, 4206683, 4213557, 4214824, 4216603, 4216604, 4240689, 4240690, 4241741, 4248462, 4249395, 4249396, 4264386, 4278302, 4278304, 4283035, 4283036, 4283037, 4283038, 4283039, 4283040, 4283041, 4285956, 4289103, 4295084, 4295085, 4298044, 4303093, 4326975, 4326979, 4326981, 4329355, 4331263, 4331265, 4331266, 4344659, 4344678, 4378973, 4482201, 4485317, 4488093, 4488094, 4490608, 4490609, 4496716, 4496915, 4496916, 4501971, 4504043, 4508068, 4513458, 4513459, 4513460, 4513461, 4516371, 4519406, 4519407, 4521408, 4525905, 4550062, 4550063, 4550064, 4550065, 4551164, 4551165, 4551166, 4561400, 4561401, 4572176, 4574481, 4580884, 4586704, 4605094, 4661414, 4669482, 4669483, 4675725, 4695343, 4705970, 4723148, 4753792, 4753794, 4777999, 4778000, 4906228, 4906229, 4914498, 4917681, 4934562, 4944809, 4956361, 4956363, 4983255, 4983256, 4983257, 5007806, 5041856, 5041857, 5041858, 5046857, 5046859, 5098159, 5113496, 5113497, 5134868, 5134869, 5143883, 5204105, 5230669, 5234395, 5234396, 5245233, 5245237, 5251710, 5292433, 5308690, 5308733, 5341509, 5370371, 5370375, 5438364, 5452452, 5465222, 5655435, 5667092, 5697537, 5726966, 5726967, 5726968, 5726969, 5726970, 5726971, 5801281, 5801284, 5801285, 5801287, 6036379, 6036381, 6168066, 6188888, 6188890, 6268389, 6268390, 6272370, 6322541, 6364587, 6553805, 6861415, 6983782, 7032568, 7505227, 7640627

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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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