FDAClass IINovember 13, 2019

Femorotibial/femoral Nail recall

FEMOROTIBIAL/FEMORAL NAIL, various sizes. Item Nos. 32855331111 32855331113 32855331115 32855331161 32855331163 32855331165

Why was Femorotibial/femoral Nail recalled?

Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).

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?

All products manufactured prior to January 2014.

Product
FEMOROTIBIAL/FEMORAL NAIL, various sizes. Item Nos. 32855331111 32855331113 32855331115 32855331161 32855331163 32855331165
Recalling firm
Zimmer Biomet, Inc.
Quantity
5,459,583 total devices
Distribution
Distributed nationwide.
Recall date
November 13, 2019
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls