Z-1753-2024Class II

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

Name: Z-1753-2024 INNOMED CUP REMOVAL STARTER INSTRUMENT, REF 520054, Hip cutter blade cup
Creator: Innomed, Inc.
Published: 2024-03-07
License: https://open.fda.gov/license/

Innomed, Inc. / initiated 2024-03-07 / Completed

FDA source

Innomed, Inc. began a recall of INNOMED CUP REMOVAL STARTER INSTRUMENT, REF 520054, Hip cutter blade cup on 2024-03-07. FDA classified it as Class II and gives the reason as "54 MM finisher blade was inadvertently affixed to the shaft of the CupX handle in lieu of the 54 MM starter blade". As of 2026-09-10, the recall status on record is Completed.

Recall record

Recall number: Z-1753-2024
Classification: Class II
Status: Completed
Initiated: 2024-03-07
Posted: 2024-05-01
Recalling firm: Innomed, Inc.
Product: INNOMED CUP REMOVAL STARTER INSTRUMENT, REF 520054, Hip cutter blade cup
Product code: HWB Extractor
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.
FDA 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 in commerce: 41 devices
Distribution: FL, GA, PA, NY, CA, VA, SD, MN, TX, UT, NC, and UK, Denmark, Germany Switzerland, Ireland, Canada
Product codes and lots: UDI/DI 00840277104007, Lot Number 1223K

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1753-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1753-2024	Class II	Completed	Voluntary: Firm initiated	2024-05-08	2024-05-01

Product code HWB

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)