FDA Medical Device Recalls (openFDA)
Zimmer Inc.: Zimmer brand NEXGEN Complete Knee Solution Rotating Hinge Knee Tibial Component, precoat, nonmodular, size 3, sterile, for cemented use only; Cat. No. 5880-03-02.
- Recall number
- Z-1448-04
- Recalling firm
- Zimmer Inc.
- Product
- Zimmer brand NEXGEN Complete Knee Solution Rotating Hinge Knee Tibial Component, precoat, nonmodular, size 3, sterile, for cemented use only; Cat. No. 5880-03-02.
- Status
- Terminated
- Initiated
- 2004-08-03
- Posted
- 2004-09-14
- Terminated
- 2004-09-13
- Reason
- The polyethylene tibial bushing was omitted from the taper of the tibial plates.
- Root cause
- Other
- Action
- Consignees were notified via recall letter dated August 3, 2004 and sent via certified mail, return receipt requested. A dear doctor letter dated August 25, 2004 was sent to the implanting physicians.
- Quantity
- not on file
- Distribution
- Nationwide (California, Florida, Illinois, Indiana, Louisiana, Michigan, Nevada, New Jersey, New York, North Carolina, Ohio, Texas, Wisconsin), and Germany.
- Lot, serial or model codes
- lot 60004557; Exp. December 2008.
- 510(k) numbers
- ["K013385"]
- PMA numbers
- not on file
- Product code
- KRO
- 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