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Terminated

979195 Loaner Kit for femoral intramedullary nail. Orthopedic instrument.

FDA Recall Z-0775-2018 · Posted None

Recalling FirmZimmer Biomet, Inc.
Recall StatusTerminated
Product CodeLXH
Date Initiated2017-09-13
Date Terminated2020-04-21
Product Quantity337 total

Reason for Recall

Fracture of the bolt connecting the insertion guide to the intramedullary nail during insertion of the femoral nail.

Firm Action

On September 13, 2017 an URGENT MEDICAL DEVICE RECALL REMOVAL was issued to customers requesting that they review inventory and quarantine affected product, which will be immediately returned to recalling firm. Also to notify any customers who may have received product. Questions or concerns can be directed to Customer Service at 574-371-3071

Root Cause

Device Design

Distribution Pattern

Distribution includes US Nationwide.

Official Source

View FDA Recall →

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

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