Z-1185-2008

Biomet brand Modular Microplasty Cup Inserter, 3/8" thread; Model 31-400600 assembled with a 3/8" threaded...

Name: Z-1185-2008 Biomet brand Modular Microplasty Cup Inserter, 3/8" thread; Model 31-400600 assembled with a 3/8" threaded...
Creator: Biomet, Inc.
Published: 2008-01-16
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2008-01-16 / Terminated / root cause: design

FDA source

Biomet, Inc. began a recall of Biomet brand Modular Microplasty Cup Inserter, 3/8" thread; Model 31-400600 assembled with a 3/8" threaded insert; Model 31-400603. Instrument for hip... on 2008-01-16. The reason FDA records is "The weld at the lock location may fracture during impaction". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1185-2008
Status: Terminated
Initiated: 2008-01-16
Posted: 2008-08-20
Terminated: 2009-09-22
Recalling firm: Zimmer GmbH
Product: Biomet brand Modular Microplasty Cup Inserter, 3/8" thread; Model 31-400600 assembled with a 3/8" threaded insert; Model 31-400603. Instrument for hip prosthesis acetabular cup component.
Product code: LXH Orthopedic Manual Surgical Instrument
Reason for recall: The weld at the lock location may fracture during impaction.
Root cause tag: design
FDA root cause: Device Design
Action: Biomet notified distributors and medical facilities by letter dated 1/16/08. Distributors with distributor-owned instruments at medical facilities were notified by email on 1/17/08, and provided with a letter to present to their associated medical facilities describing the recall.
Quantity in commerce: 315
Distribution: Worldwide Distribution: USA, Germany, Mexico, Netherlands, Sweden and United Kingdom.
Product codes and lots: Lots: 095116, 095117, 096758, 0967822 and 096824.

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)