Recall Z-1804-2010 ยท LXH Orthopedic Manual Surgical Instrument
Synthes USA (HQ), Inc.
Synthes Medullary Tubes
| Date | Jun 16, 2010 (initiated Apr 1, 2010) |
| Status | Terminated |
| Reason | After repeated sterilizations product may become discolored and break including while in the medullary canal. Synthes has determined that the Medullary Tube will be a single use item that is to be discarded after one sterilization cycle. |
| Root cause | Other |
| Action | The recalling firm issued an Urgent medical Device Recall letter dated 4/9/10 to all trauma hospital accounts informing them of the problem and the need to return the products. All sales consultants were notified via email and letter. Questions are directed to the company at 800-620-7025 x 5452 or 610-719-5452, or contact your Synthes Trauma Sales Consultant. |
| Quantity | 18,505 tubes |
| Distribution | The product was shipped to medical facilities nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.