Recall Z-2811-2015 ยท GXN Plate, Cranioplasty, Preformed, Non-Alterable
Synthes (USA) Products LLC
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.
| Date | Sep 23, 2015 (initiated Aug 31, 2015) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Labeling False and Misleading |
| Action | DePuy Synthes sent an URGENT:FIELD SAFETY NOTIFICATION / MEDICAL DEVICE LABELING CORRECTION letter, dated August 31, 2015 to affected customers. The letter identified affected product, problem and actions to be taken. Customers were instructed to: "Update and review the package insert (GP1345-D). " Discard outdated package insert noted in the table above. " Forward this Field Safety Notification to anyone in your facility that needs to be informed, especially personnel that conduct MR testing. " If the package insert has been forwarded to another facility, contact that facility. " Complete |
| Quantity | 105882 |
| Distribution | US Nationwide and internationally, including Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K992000 | SYNTHES CRANIAL FLAP TUBE CLAMP Synthes (Usa), Jul 20, 1999 |