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Terminated

Biomet Microplasty Cup Impactor, 1/4" -28 Thread Insert; Model 31-400605. Instrument for hip prosthesis acetabular cup component.

FDA Recall Z-1187-2008 · Posted 2008-08-20

Recalling FirmBiomet, Inc.
Recall StatusTerminated
Product CodeLXH
Date Initiated2008-01-16
Date Terminated2009-09-22
Product Quantity630

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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