Synthes Cranial Flap Tube Clamp and Crimping Device Product Usage:… — Class II medical device recall Z-2811-2015
Terminated recall by Synthes (USA) Products LLC, reported 2015-09-30, distributed nationwide. The Synthes Cranial Flap Tube Clamp and Crimping Device for Cranial Tube Clamp had been labeled MR Safe althou
| Recall number | Z-2811-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Synthes (USA) Products LLC, West Chester, PA, United States |
| Recall initiated | 2015-08-31 |
| Classified | 2015-09-23 |
| Reported by FDA | 2015-09-30 |
| Terminated | 2016-08-18 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 105,882 |
| Reason classes | labeling |
| 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 and 114 more |
| Model numbers | 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 |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2811-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.