FDA Medical Device Recalls (openFDA)
Zimmer Inc.: Zimmer NexGen Complete Knee Solution Legacy Knee - Posterior Stabilized LPS-Flex Femoral Component Precoat, Size D left , sterile, Zimmer, Warsaw, IN; REF 00-5960-014-51.
- Recall number
- Z-1520-2009
- Recalling firm
- Zimmer Inc.
- Product
- Zimmer NexGen Complete Knee Solution Legacy Knee - Posterior Stabilized LPS-Flex Femoral Component Precoat, Size D left , sterile, Zimmer, Warsaw, IN; REF 00-5960-014-51.
- Status
- Terminated
- Initiated
- 2009-04-17
- Posted
- 2009-06-25
- Terminated
- 2009-11-12
- Reason
- The implant surface may not have been polished adequately, which could result in increased wear and polyethylene debris generation.
- Root cause
- Employee error
- Action
- Consignees were notified by phone beginning on 4/17/09 and email and letter notifications were sent on 4/22/09. A dear surgeon letter entitled Urgent: Medical Device Recall, dated April 28, 2009, is being sent to implanting surgeons recommending patient monitoring. Consignees are to return the response form indicating their receipt of the notification. Questions or concerns should be directed to (800) 846-4637 or www.zimmer.com.
- Quantity
- 5
- Distribution
- Worldwide Distribution -- USA including states of Arizona, California, Colorado, Hawaii, Illinois, Indiana, Michigan, Minnesota, Mississippi, New Jersey, New Mexico, New York, Ohio, Oregon, and Pennsylvania and country of Canada.
- Lot, serial or model codes
- Lot 61208295.
- 510(k) numbers
- not on file
- PMA numbers
- ["P060037"]
- Product code
- NJL
- 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