Recall Z-0202-2014 ยท LXH Orthopedic Manual Surgical Instrument
Synthes USA HQ, Inc.
Synthes 8.5 MM Medullary Reamer Product Usage: An orthopedic manual surgical instrument is a nonpowered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery. This generic type of device includes the cerclage applier, awl, bender, drill brace, broach, bmT, corkscrew, countersink, pin crimper, wire cutter, prosthesis driver, extra
| Date | Nov 13, 2013 (initiated Oct 3, 2013) |
| Status | Terminated |
| Reason | Complaints were received for intraoperative reamer head breakages which can allow for unretrieved fragments of non-implant grade material. |
| Root cause | Device Design |
| Action | Synthes sent an Urgent Notice: Voluntary Medical Device Recall Notification letters, dated October 3, 2013, to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to review their inventory and immediately remove the affected lots from stock. For questions call 610-719-5450 or contact your Synthes Sales Consultant. |
| Quantity | 2979 |
| Distribution | Worldwide Distribution: USA (Nationwide) and countries of: Canada and Mexico. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.