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Terminated

Biomet brand Modular Microplasty Cup Inserter, 3/8" thread, Biomet Orthopedics, Inc., Warsaw, IN; Model 31-400600. Non-powered, hand-held instrument intended for use as an impactor during orthopedic surgery.

FDA Recall Z-0181-2009 · Posted 2008-10-24

Recalling FirmBiomet, Inc.
Recall StatusTerminated
Product CodeLXH
Date Initiated2008-07-28
Date Terminated2009-09-22
Product Quantity85

Reason for Recall

The pin and clip may fracture during use.

Firm Action

Consignees were notified by recall letter dated 7/28/08 to remove the recalled lots from use and to return them. Contact Biomet, Inc. at 1-800-348-9500 or 1- 574-372-3983 for assistance.

Root Cause

Device Design

Distribution Pattern

Nationwide, Australia, Belgium, Canada, Denmark, New Zealand and Sweden.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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