Innomed Cup Removal Starter Instrument (Innomed) – Incorrect Blade Placement (2024)
Incorrect blade attachment may cause potential surgical instrument misuse.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
INNOMED CUP REMOVAL STARTER INSTRUMENT, REF 520054, Hip cutter blade cup
Brand
Innomed, Inc.
Lot Codes / Batch Numbers
UDI/DI 00840277104007, Lot Number 1223K
Products Sold
UDI/DI 00840277104007, Lot Number 1223K
Innomed, Inc. is recalling INNOMED CUP REMOVAL STARTER INSTRUMENT, REF 520054, Hip cutter blade cup due to 54 MM finisher blade was inadvertently affixed to the shaft of the CupX handle in lieu of the 54 MM starter blade.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
54 MM finisher blade was inadvertently affixed to the shaft of the CupX handle in lieu of the 54 MM starter blade.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
CA, FL, GA, MN, NY, NC, PA, SD, TX, UT, VA
Page updated: Jan 10, 2026