FDA Medical Device Recalls (openFDA)
Zimmer Inc.: Zimmer, Insall/Burstein II Modular Knee System, Tibial Wedge and 2 Screws, Size 59, 7 Deg. x 9.5 mm Height, Tivanium TI-6AL-4V Alloy, sterile; REF 5220-62-01.
- Recall number
- Z-0555-2010
- Recalling firm
- Zimmer Inc.
- Product
- Zimmer, Insall/Burstein II Modular Knee System, Tibial Wedge and 2 Screws, Size 59, 7 Deg. x 9.5 mm Height, Tivanium TI-6AL-4V Alloy, sterile; REF 5220-62-01.
- Status
- Terminated
- Initiated
- 2009-02-26
- Posted
- 2009-12-22
- Terminated
- 2011-02-28
- Reason
- Smaller diameter screws than required were included in the package.
- Root cause
- Process control
- Action
- Zimmer notified consignees by recall letter dated 2/25/09 instructing them to cease use of the device and to return it. Zimmer distributors and international accounts were notified by email on 2/26/09.
- Quantity
- 13
- Distribution
- USA (Connecticut, Indiana, Pennsylvania), Australia, Serbia, Spain, Switzerland and the United Kingdom.
- Lot, serial or model codes
- Lot 07878240.
- 510(k) numbers
- ["K862632"]
- PMA numbers
- not on file
- Product code
- HSX
- Firm FEI
- 1000220733
- 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