FDA Medical Device Recalls (openFDA)
Innomed, Inc.: INNOMED CUP REMOVAL STARTER INSTRUMENT, REF 520054, Hip cutter blade cup
- Recall number
- Z-1753-2024
- Recalling firm
- Innomed, Inc.
- Product
- INNOMED CUP REMOVAL STARTER INSTRUMENT, REF 520054, Hip cutter blade cup
- Status
- Completed
- Initiated
- 2024-03-07
- Posted
- 2024-05-01
- Terminated
- not on file
- Reason
- 54 MM finisher blade was inadvertently affixed to the shaft of the CupX handle in lieu of the 54 MM starter blade.
- Root cause
- Under Investigation by 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.
- Quantity
- 41 devices
- Distribution
- FL, GA, PA, NY, CA, VA, SD, MN, TX, UT, NC, and UK, Denmark, Germany Switzerland, Ireland, Canada
- Lot, serial or model codes
- UDI/DI 00840277104007, Lot Number 1223K
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- HWB
- Firm FEI
- 1833053
- Firm city
- Savannah
- Firm state
- GA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28