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Terminated

Biomet Dual Offset Broach Handle, Clamping Style, Left, REF 31-555403. For use in primary hip arthroplasty.

FDA Recall Z-1352-2009 · Posted 2009-06-01

Recalling FirmBiomet, Inc.
Recall StatusTerminated
Product CodeLXH
Date Initiated2009-03-31
Date Terminated2009-12-23
Product Quantity178 of all products.

Reason for Recall

The handle body may fracture or crack at the slot where the locking lever is inserted to clamp down onto the broach.

Firm Action

Biomet notified their distributors by recall letter dated 3/31/09, instructed them to pick up the insturments at the hospitals and to notify the hospital personnel of this recall action in writing.

Root Cause

Device Design

Distribution Pattern

Nationwide, Canada and Finland.

Official Source

View FDA Recall →

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

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