Recall Z-0410-2014 ยท OAR Injector, Vertebroplasty (Does Not Contain Cement)
Synthes USA HQ, Inc.
Vertebroplasty Needle Kit 10g Diamond Tip Intended to be used to inject PMMA cement into vertebral bodies during Vertebroplasty procedure.
| Date | Nov 27, 2013 (initiated Jul 30, 2013) |
| Status | Terminated |
| Reason | Complaints were received of inconsistencies in the expiration dates shown on the packaging of the Vertebroplasty Needle Kit 10g Diamond Tip device. |
| Root cause | Incorrect or no expiration date |
| Action | Synthes sent an Urgent Notice: Medical Device Notification letter dated October 8, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to returny any of the affect devices, call Synthes at 1-800-479-6329 to obtain a Return Authorization Number, complete the Verification Section indicating the affected product has been located, also indicate the number of devices found and note the Return Authorization Number. Return the Verification Form to: Credit/Returns Synthes 1101 Synthes Avenue Monumen |
| Quantity | 40 |
| Distribution | Nationwide Distribution including IN, MT, HI, and FL. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.