FDA Medical Device Recalls (openFDA)
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.
- Recall number
- Z-0646-2010
- Recalling firm
- Biomet, Inc.
- Product
- 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.
- Status
- Terminated
- Initiated
- 2009-12-01
- Posted
- 2010-01-15
- Terminated
- 2010-10-18
- 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.
- Lot, serial or model codes
- Lots 122890, 296900, 424590, 433560, 433570, 433580, 433590, 433600, 646610 and 943990.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LXH
- Firm FEI
- 1825034
- Firm city
- Warsaw
- Firm state
- IN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28