FDAClass IINovember 13, 2019

Sidus Stem-Free Shoulder Humeral Head recall

Sidus Stem-Free Shoulder Humeral Head, Item Nos. 0104555380 0104555400 0104555420 0104555440 0104555460 0104555480 0104555485 0104555500 0104555505…

Why was Sidus Stem-Free Shoulder Humeral Head 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
Sidus Stem-Free Shoulder Humeral Head, Item Nos. 0104555380 0104555400 0104555420 0104555440 0104555460 0104555480 0104555485 0104555500 0104555505…
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