FDAClass IIOctober 14, 2020

Biomet Regenerex Primary Taper Cap recall

Biomet Regenerex Primary Taper Cap Item Number 141269

Why was Biomet Regenerex Primary Taper Cap recalled?

Product not properly being aligned with the adequate gamma sterilization group and result in the product not being properly sterilized

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?

Lot Numbers: 015800 324440 685300 023900 324440R 696280 058930 389060 821980 200720 418430 890320 313260 646040 997610

Product
Biomet Regenerex Primary Taper Cap Item Number 141269
Recalling firm
Biomet, Inc.
Quantity
US: 62 units; OUS: 176 units
Distribution
Nationwide Foreign: Canada, FINLAND, NETHERLANDS, UNITED KINGDOM
Recall date
October 14, 2020
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls