Synthes Cranial Flap Tube Clamp and Crimping Device recall
Synthes Cranial Flap Tube Clamp and Crimping Device Product Usage: The Synthes Cranial Flap Tube Clamp System is intended to reattach a cranial bone…
Why was Synthes Cranial Flap Tube Clamp and Crimping Device 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- Product
- Synthes Cranial Flap Tube Clamp and Crimping Device Product Usage: The Synthes Cranial Flap Tube Clamp System is intended to reattach a cranial bone…
- Recalling firm
- Synthes (USA) Products LLC
- Quantity
- 105882
- Distribution
- US Nationwide and internationally, including Canada.
- Recall date
- September 30, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)