Osteobond Bone Cement Bone cement monomer is kitted with bone cement powder to create a cement mantle for orthopedic implants.
Recall
- Recall Number
- Z-0900-2015
- Event Number
- 69904
- Firm
- Zimmer, Inc.
- FEI Number
- 1000220733
- Product Code
- LOD
- Status
- Terminated
- Root Cause
- Employee error
- Initiated
- December 8, 2014
- Posted
- December 31, 2014
- Terminated
- July 17, 2015
- Address
- 1800 W Center St, Warsaw, IN, 46580-2304
Description
Osteobond Bone Cement Bone cement monomer is kitted with bone cement powder to create a cement mantle for orthopedic implants.
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.
"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.
Distributed to MI, KS, and CA.
40 units