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Completed

INNOMED CUP REMOVAL STARTER INSTRUMENT, REF 520054, Hip cutter blade cup

FDA Recall Z-1753-2024 · Posted 2024-05-01

Recalling FirmInnomed, Inc.
Recall StatusCompleted
Product CodeHWB
Date Initiated2024-03-07
Product Quantity41 devices

Reason for Recall

54 MM finisher blade was inadvertently affixed to the shaft of the CupX handle in lieu of the 54 MM starter blade.

Firm Action

Innomed issued an urgent medical device recall notice to its consignees on 03/07/2024 via email. The notice explained the issue, potential risk to health, and requested the return of the affected devices for US distribution and destruction of the affected devices distributed outside the US.

Root Cause

Under Investigation by firm

Distribution Pattern

FL, GA, PA, NY, CA, VA, SD, MN, TX, UT, NC, and UK, Denmark, Germany Switzerland, Ireland, Canada

Official Source

View FDA Recall →

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

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