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Terminated

fastener, fixation, nondegradable, soft tissue

FDA Recall Z-1009-2018 · Posted None

Recalling FirmZimmer Biomet, Inc.
Recall StatusTerminated
Product CodeMBI
Date Initiated2017-10-25
Date Terminated2020-05-12
Product Quantity429 units

Reason for Recall

It was identified that the product was not assembled correctly causing the implant shaft to shift and fall out during the opening of the device, which potentially could break the device.

Firm Action

In October of 2017 an URGENT MEDICAL DEVICE RECALL LETTER was issued to customers requesting that any remaining product be quarantined and returned to recalling firm. Questions or concerns can be directed to 574-371-3071.

Root Cause

Process control

Distribution Pattern

TX, NC, FL, PA, IN, WI, VA, NY, NJ, AL, CT

Official Source

View FDA Recall →

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

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