Z-0991-2009

Zimmer Minimally Invasive Solutions Technology Offset Rasp Handle, Right, 30 degrees, Zimmer, Warsaw, IN; REF...

Name: Z-0991-2009 Zimmer Minimally Invasive Solutions Technology Offset Rasp Handle, Right, 30 degrees, Zimmer, Warsaw, IN; REF...
Creator: Zimmer Inc.
Published: 2008-12-19
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2008-12-19 / Terminated / root cause: labeling and UDI

FDA source

Zimmer Inc. began a recall of Zimmer Minimally Invasive Solutions Technology Offset Rasp Handle, Right, 30 degrees, Zimmer, Warsaw, IN; REF 00-7806-035-02. The offset rasp handle is a... on 2008-12-19. The reason FDA records is "The c-clip located near the connection end may fracture or fall off during use in surgical procedures". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0991-2009
Status: Terminated
Initiated: 2008-12-19
Posted: 2009-02-27
Terminated: 2009-12-22
Recalling firm: Zimmer GmbH
Product: Zimmer Minimally Invasive Solutions Technology Offset Rasp Handle, Right, 30 degrees, Zimmer, Warsaw, IN; REF 00-7806-035-02. The offset rasp handle is a surgical instrument used with various sizes of femoral rasps to prepare the femoral canal for a hip implant.
Product code: LXH Orthopedic Manual Surgical Instrument
Reason for recall: The c-clip located near the connection end may fracture or fall off during use in surgical procedures.
Root cause tag: labeling and UDI
FDA root cause: Labeling design
Action: U.S. consignees were notified by "Urgent: Device Recall" letter issued via e-mail on December 19, 2008. The letter described the problem and instructed customers to immediately quarantine and return the recalled product along with the completed Inventory Return Certification form to the Zimmer, Inc. Distribution Center. Consignees were also instructed to fax a copy of the completed Inventory Return Certification Form at 1-574-371-8603. International consignees were also notified, but Zimmer, Inc. will gather the instruments from those customers. Direct questions about the recall to Zimmer, Inc. at 1-800-613-6131.
Quantity in commerce: 1,461 of both products.
Distribution: Worldwide Distribution --- including USA, Belgium, Czech Republic, Finland, Germany, Greece, Italy, Poland, Romania, Spain and United Kingdom.
Product codes and lots: Lot Numbers: 60244767, 60254985, 60270484, 60283990, 60291761, 60295682,60298345, 60327534, 60332316, 60337990, 60347614, 60363922, 60395585, 60406637, 60416986, 60453034, 60468964, 60482887, 60517611, 60688076 and 60810866.

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)