Reported Sep 30, 2015 · Terminated
Synthes Cranial Flap Tube Clamp and Crimping Device Product Usage: The Synthes Cranial Flap Tube Clamp System is…
Synthes (USA) Products LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Synthes (USA) Products LLC · 1301 Goshen Pkwy · West Chester, PA · 19380-5986
Is this the product you have?
- Synthes Cranial Flap Tube
- Clamp and Crimping Device Product UsageThe Synthes Cranial Flap Tube Clamp System is intended to reattach a cranial bone flap to the surrounding cranium after a craniotomy procedure
- Lot codes and dates
- Part Numberwith 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
329.315460.001460.001.01S460.002460.002.01S460.003460.003.01S460.008460.008.01S460.009460.009.01S460.010460.010.01S460.100460.100.01S460.107460.107.01S
- Part Number
- Amount recalled
- 105882
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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