FDA Medical Device Recalls (openFDA)
Biomet, Inc.: OSS (Orthopedic Salvage System) RS Non-Modular Long Tibial Base, Porous Coated, 71mm x 10 x 160mm, Co-CR-MO/Ti-6AL-4V alloy, sterile; Part 161043. Implant is part of a system used to replace the tibial portion of the knee joint.
- Recall number
- Z-2213-2008
- Recalling firm
- Biomet, Inc.
- Product
- OSS (Orthopedic Salvage System) RS Non-Modular Long Tibial Base, Porous Coated, 71mm x 10 x 160mm, Co-CR-MO/Ti-6AL-4V alloy, sterile; Part 161043. Implant is part of a system used to replace the tibial portion of the knee joint.
- Status
- Terminated
- Initiated
- 2007-11-07
- Posted
- 2008-09-17
- Terminated
- 2009-03-13
- Reason
- Mislabeled as to size: Product is labeled as reduced size, but is actually standard size.
- Root cause
- Labeling mix-ups
- Action
- Consignees were notified by an Urgent Medical Device Recall Notice letter dated 11/7/07. The letter required that use of the product be immediately discontinued and that components be returned to Biomet. Letters to hospital administrators and the five implanting surgeons were issued on/or about 5/6/08 advising them of the problem and to perform patient evaluations.
- Quantity
- 22
- Distribution
- Nationwide Distribution --- including states of California, Florida, Illinois, Indiana, Massachusetts, Missouri, New Jersey, Oklahoma, Pennsylvania, Texas, Virginia and Washington.
- Lot, serial or model codes
- Lots 053850, Exp 08/2016; 070890, Exp 08/2016; 201930, Exp 09/2016; 364790, Exp 10/2016; 507290, Exp 11/2016 and 534910, Exp 04/2017.
- 510(k) numbers
- ["K052685"]
- PMA numbers
- not on file
- Product code
- KRO
- 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