Z-0518-2009

Compress Instrument 13mm Anchor Plug Holder, stainless steel/TiAIN, Biomet Orthopedics, Inc., Warsaw, IN; REF...

Name: Z-0518-2009 Compress Instrument 13mm Anchor Plug Holder, stainless steel/TiAIN, Biomet Orthopedics, Inc., Warsaw, IN; REF...
Creator: Biomet, Inc.
Published: 2008-07-18
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2008-07-18 / Terminated / root cause: manufacturing process

FDA source

Biomet, Inc. began a recall of Compress Instrument 13mm Anchor Plug Holder, stainless steel/TiAIN, Biomet Orthopedics, Inc., Warsaw, IN; REF 32-481091. Non-powered, hand-held device intended... on 2008-07-18. The reason FDA records is "The set screw may not fully seat, which will prevent the handle from mating to the instrument 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-0518-2009
Status: Terminated
Initiated: 2008-07-18
Posted: 2009-01-07
Terminated: 2009-07-07
Recalling firm: Zimmer GmbH
Product: Compress Instrument 13mm Anchor Plug Holder, stainless steel/TiAIN, Biomet Orthopedics, Inc., Warsaw, IN; REF 32-481091. Non-powered, hand-held device intended for medical purposes for use with other devices in orthopedic surgery.
Product code: LXH Orthopedic Manual Surgical Instrument
Reason for recall: The set screw may not fully seat, which will prevent the handle from mating to the instrument during use.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Distributors were notified via an Urgent Medical Device Removal Notice, dated 7/18/08, which instructed them to locate and remove the instruments, carefully follow the instructions on the enclosed "FAX Back Response Form," fax a copy of the Response Form to 574-372-1683 prior to return of product, and to notify the hospital personnel via a copy of a recall letter. The letter also stated that the instruments would be reworked and returned to the distributors. Distributors are to confirm receipt of the notice by calling, 800-348-9500, ext 3983. Questions related to the notice should be directed to Mary Hardesty at 800-348-9500 or 574-372-3983.
Quantity in commerce: 41 of all products.
Distribution: Worldwide Distribution --- including USA and countries of Australia, Belgium and Finland.
Product codes and lots: Lots 054890, 638720, 622160, 836690, and 599490.

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)