Cobalt MV with Gentamicin, Cobalt Bone Cement 40GM, REF 402439, QTY 1, STERILE, Rx Only, Mfgr: BIOMET ORTHOPEDICS Cobalt

FDA device recall Z-0066-2018 · posted 2017-11-06 · Open, Classified

Recall details

Recalling firm

Encore Medical, Lp

Reason for recall

Loss of the seal on the sterile Tyvek packaging used with this Cobalt Bone Cement.

Action taken

Zimmer Biomet sent an Urgent Medical Device Recall Notice dated April 2017 to all affected customers. The firm initiated their recall to their distributors on 06/26/2017 requesting that they destroy any product on hand. The firm then expanded their recall on 09/14/2017, beginning their notification by email and following with letters to hospitals delivered on 09/21 and 09/22/2017. The firm requested the following actions: "1. Complete the Acknowledgement/Questionnaire provided with this lot specific field safety notice and return to Stericycle by email to DJO5504@stericycle.com or by fax to 866-608-3939. If you have any questions or issues related to sending this information, please call 877-551-7153. 2. Quarantine this affected product. Arrangements will be made to finalize the handling of the product as well as coordinate the replacement product where applicable. 3. If packaging issues are found, please contact DJO Surgical Customer Service to initiate a product complaint." Customers with questions were instructed to call 512-834-6255.

Root cause

Vendor change control

Status

Open, Classified

Product code

LOD

Quantity affected

1815 units

Distribution

Nationwide Distribution

Date initiated

2017-06-26

Date posted

2017-11-06

Location

Austin, TX

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