FDA Medical Device Recalls (openFDA)
Zimmer Inc.: Zimmer NEXGEN Complete Knee Solution articular surface insertion instrument, non-sterile. This device is a surgical instrument used during knee arthroplasty procedures to snap or lock the polyethylene bearing surface into the retaining rail on a metal tibial plate.
- Recall number
- Z-1863-2008
- Recalling firm
- Zimmer Inc.
- Product
- Zimmer NEXGEN Complete Knee Solution articular surface insertion instrument, non-sterile. This device is a surgical instrument used during knee arthroplasty procedures to snap or lock the polyethylene bearing surface into the retaining rail on a metal tibial plate.
- Status
- Terminated
- Initiated
- 2008-05-16
- Posted
- 2008-09-11
- Terminated
- 2009-11-12
- Reason
- The instrument is prone to fracture during use.
- Root cause
- Process control
- Action
- Direct and hospital consignees were notified via email or letter on 5/16/08 to cease use and return the instruments. Contact Kevin W. Escapule at 800-846-4637 if you have questions.
- Quantity
- 500
- Distribution
- Nationwide, Australia, Canada, China, Germany, India, Japan, Korea, Mexico, Singapore, Spain, Sweden and Taiwan.
- Lot, serial or model codes
- Lots 60577285, 60582624, 60587308, 60603255 and 60610860.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LXH
- 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