FDAClass IIMay 8, 2024

Innomed CUP Removal Starter Instrument recall

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

Why was Innomed CUP Removal Starter Instrument recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

UDI/DI 00840277104007, Lot Number 1223K

Product
INNOMED CUP REMOVAL STARTER INSTRUMENT, REF 520054, Hip cutter blade cup
Recalling firm
Innomed, Inc.
Quantity
41 devices
Distribution
FL, GA, PA, NY, CA, VA, SD, MN, TX, UT, NC, and UK, Denmark, Germany Switzerland, Ireland, Canada
Recall date
May 8, 2024
Classification
Class II
Status
Completed
Agency
FDA (device)
Open FDA enforcement record Latest recalls