FDAClass IINovember 13, 2019

CLS Brevius Stem Kinectiv recall

CLS Brevius Stem Kinectiv, hip prosthesis, various sizes. Item Nos. 0100296050 0100296060 0100296070 0100296080 0100296090 0100296100 0100296112…

Why was CLS Brevius Stem Kinectiv 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 product manufactured prior to January 2014.

Product
CLS Brevius Stem Kinectiv, hip prosthesis, various sizes. Item Nos. 0100296050 0100296060 0100296070 0100296080 0100296090 0100296100 0100296112…
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