Z-0102-2008

Biomet Orthopedics Apical Hole Plug, 3/8 - 24 threaded, TI-6AL-4V alloy, sterile; REF 123741, Biomet...

Name: Z-0102-2008 Biomet Orthopedics Apical Hole Plug, 3/8 - 24 threaded, TI-6AL-4V alloy, sterile; REF 123741, Biomet...
Creator: Biomet, Inc.
Published: 2007-08-09
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2007-08-09 / Terminated / root cause: manufacturing process

FDA source

Biomet, Inc. began a recall of Biomet Orthopedics Apical Hole Plug, 3/8 - 24 threaded, TI-6AL-4V alloy, sterile; REF 123741, Biomet Orthopedics, Inc., Warsaw, IN 46581 on 2007-08-09. The reason FDA records is "Incorrect or lack of threading: The plug component was manufactured incorrectly and does not fit with the screw hole as intended". 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-0102-2008
Status: Terminated
Initiated: 2007-08-09
Posted: 2007-10-27
Terminated: 2009-06-26
Recalling firm: Zimmer GmbH
Product: Biomet Orthopedics Apical Hole Plug, 3/8 - 24 threaded, TI-6AL-4V alloy, sterile; REF 123741, Biomet Orthopedics, Inc., Warsaw, IN 46581
Product code: LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Reason for recall: Incorrect or lack of threading: The plug component was manufactured incorrectly and does not fit with the screw hole as intended.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: The distributor was notified via phone on or about 8/9/07 and by letter dated 8/31/07 and requested to return the product. Returns included subaccounts
Quantity in commerce: 5
Distribution: Nationwide
Product codes and lots: Lot 522080.

Product code LPH

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)