Z-1863-2008

Zimmer NEXGEN Complete Knee Solution articular surface insertion instrument, non-sterile. This device is a...

Name: Z-1863-2008 Zimmer NEXGEN Complete Knee Solution articular surface insertion instrument, non-sterile. This device is a...
Creator: Zimmer Inc.
Published: 2008-05-16
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2008-05-16 / Terminated / root cause: manufacturing process

FDA source

Zimmer Inc. began a recall of Zimmer NEXGEN Complete Knee Solution articular surface insertion instrument, non-sterile. This device is a surgical instrument used during knee arthroplasty... on 2008-05-16. The reason FDA records is "The instrument is prone to fracture during use". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1863-2008
Status: Terminated
Initiated: 2008-05-16
Posted: 2008-09-11
Terminated: 2009-11-12
Recalling firm: Zimmer GmbH
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.
Product code: LXH Orthopedic Manual Surgical Instrument
Reason for recall: The instrument is prone to fracture during use.
Root cause tag: manufacturing process
FDA 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 in commerce: 500
Distribution: Nationwide, Australia, Canada, China, Germany, India, Japan, Korea, Mexico, Singapore, Spain, Sweden and Taiwan.
Product codes and lots: Lots 60577285, 60582624, 60587308, 60603255 and 60610860.

Product code LXH

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)