Biomet Vanguard Lock-On Femoral Impactor, Biomet Orthopedics. Warsaw. IN; REF 32-486206. Non-powered, hand-held device i
FDA device recall Z-0646-2010 · posted 2010-01-15 · Terminated
Recall details
- Recalling firm
- Biomet, Inc.
- Reason for recall
- The locking hook tabs may fracture and fragments remain in the patient post-operatively.
- Action taken
- 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.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- LXH
- Quantity affected
- 92
- Distribution
- Worldwide Distribution -- USA, Canada, China, Costa Rica, Denmark, Germany, Netherlands, New Zealand, and United Kingdom.
- Date initiated
- 2009-12-01
- Date posted
- 2010-01-15
- Date terminated
- 2010-10-18
- Location
- Warsaw, IN
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