Z-0317-2008

Zimmer Minimally Invasive Solutions Technology Offset Rasp Handle, Right, 45 degrees, non-sterile; REF...

Name: Z-0317-2008 Zimmer Minimally Invasive Solutions Technology Offset Rasp Handle, Right, 45 degrees, non-sterile; REF...
Creator: Zimmer Inc.
Published: 2007-06-28
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2007-06-28 / Terminated / root cause: manufacturing process

FDA source

Zimmer Inc. began a recall of Zimmer Minimally Invasive Solutions Technology Offset Rasp Handle, Right, 45 degrees, non-sterile; REF 7712-35-02, Zimmer U.K. Ltd., SN3, 4FP, UK on 2007-06-28. The reason FDA records is "Clip Detachment: The retainer c-clip can detach from the instrument during use and may fall into the surgical wound". 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-0317-2008
Status: Terminated
Initiated: 2007-06-28
Posted: 2007-12-15
Terminated: 2008-03-17
Recalling firm: Zimmer GmbH
Product: Zimmer Minimally Invasive Solutions Technology Offset Rasp Handle, Right, 45 degrees, non-sterile; REF 7712-35-02, Zimmer U.K. Ltd., SN3, 4FP, UK
Product code: LXH Orthopedic Manual Surgical Instrument
Reason for recall: Clip Detachment: The retainer c-clip can detach from the instrument during use and may fall into the surgical wound
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Zimmer notified their distributors via Product Recall Notification Letter dated 6/30/07 and instructed them to notify their customers of the recall and to pick up the product and return it to Zimmer.
Quantity in commerce: 62 (total for Z-0316-0317-2008)
Distribution: Worldwide: USA including states of Arizona, California, Florida, Georgia, Indiana, Michigan, New York, North Carolina, and Virginia, and countries of Germany and Japan.
Product codes and lots: Lot No: 60651168 and 60726506.

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)