Recall Z-0394-2014 ยท HTN Washer, Bolt Nut
Synthes USA HQ, Inc.
Synthes Spiked Washers 13.5/6.5 Spiked Washers 13.5/6.5 are intended to be used in ligament reattachment or fixation, specifically readaptation of torn or avulsed ligaments.
| Date | Nov 26, 2013 (initiated Oct 3, 2013) |
| Status | Terminated |
| Reason | During a retrospective assessment, Spiked Washers 13.5/6.5 were discovered to be mislabeled as Spiked Washers 13.5/5.5. |
| Root cause | Finished device change control |
| Action | SYNTHES sent an Urgent Notice: Medical Device Recall letter dated October 3, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed call Synthes at 1-800-479-6329 to obtain a Return Authorization Number, complete the Verification Section at the end of the letter by checking the appropriate box indicating affected product located. Return the Verification Form to: Credit/Returns Synthes 1101 Synthes Avenue, Monument, CO 80132 Customers were also asked to return the Verification Form indicating |
| Quantity | 3087 |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K011583 | SPIKED WASHER Synthes (Usa), Jan 30, 2002 |