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.
FDA Recall Z-1185-2008 · Posted 2008-08-20
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Recalling FirmBiomet, Inc.
Recall StatusTerminated
Product CodeLXH
Date Initiated2008-01-16
Date Terminated2009-09-22
Product Quantity315
Reason for Recall
The weld at the lock location may fracture during impaction.
Firm 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.
Root Cause
Device Design
Distribution Pattern
Worldwide Distribution: USA, Germany, Mexico, Netherlands, Sweden and United Kingdom.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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