Osteobond Bone Cement Bone cement monomer is kitted with bone cement powder to create a cement mantle for orthopedic imp

FDA device recall Z-0900-2015 · posted 2014-12-31 · Terminated

Recall details

Recalling firm

Zimmer, Inc.

Reason for recall

Samples of product from Supplier lot 14D0809 and 14D0808 showed little adhesive transfer between the Tyvek lid and cavity when opened for internal bone cement cure and pairing tests. Visually these samples do not meet the requirements of ZWI 43.109 and corresponding visual aid 55-0000-310-01.

Action taken

"Urgent Medical Device Recall - Lot Specific" notifications will be sent to the affected distributors, surgeons, and hospital risk managers with instructions for returning the affected product. The letters identified the affected product, reason for recall, risks, and responsibilities. Customers are to complete and return the Inventory Return Certification Form along with the affected product. Questions should be directed to the customer call at 1-800-348-2759.

Root cause

Employee error

Status

Terminated

Product code

LOD

Quantity affected

40 units

Distribution

Distributed to MI, KS, and CA.

Date initiated

2014-12-08

Date posted

2014-12-31

Date terminated

2015-07-17

Location

Warsaw, IN