Recall Z-0646-2010 ยท LXH Orthopedic Manual Surgical Instrument
Biomet, Inc.
Biomet Vanguard Lock-On Femoral Impactor, Biomet Orthopedics. Warsaw. IN; REF 32-486206. Non-powered, hand-held device intended for medical purposes for use with other devices in orthopedic surgery; impactor.
| Date | Jan 15, 2010 (initiated Dec 1, 2009) |
| Status | Terminated |
| Reason | The locking hook tabs may fracture and fragments remain in the patient post-operatively. |
| Root cause | Device Design |
| Action | Urgent Medical Device Recall Notices were sent to distributors on 12/01/2009 with a notice for them to provide to medical facilities where distributor-owned inventory is stored. Distributors were instructed to immediately locate and remove the instruments from circulation; follow the instructions on the "FAX Back Response Form" and fax a copy back prior to returning the product; and to return the product to the firm. Questions should be directed to 800-348-9500. |
| Quantity | 92 |
| Distribution | Worldwide Distribution -- USA, Canada, China, Costa Rica, Denmark, Germany, Netherlands, New Zealand, and United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.