Recall Z-0405-2014 ยท LXH Orthopedic Manual Surgical Instrument
Synthes USA HQ, Inc.
Synthes Implant Holder for Synfix (TM)-LR the Synthes Implant Holder for Synfix (TM)-LR is a non-powered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery
| Date | Nov 27, 2013 (initiated Oct 8, 2013) |
| Status | Terminated |
| Reason | Complaints were received which described the SynFix LR implant holder breaking at the interface between the implant and the holder. |
| Root cause | Unknown/Undetermined by firm |
| 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 | 548 |
| Distribution | Worldwide Distribution - USA (nationwide) and Internationally to Canada . |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.