Osteobond Bone Cement Bone cement monomer is kitted with bone cement powder to create a cement mantle for orthopedic implants.
This recall has been terminated (originally issued December 31, 2014).
- Company
- Zimmer Inc.
- Recall Initiated
- December 8, 2014
- Posted
- December 31, 2014
- Terminated
- July 17, 2015
- Recall Number
- Z-0900-2015
- Quantity
- 40 units
- Firm Location
- Warsaw, IN
- Official Source
- View on FDA website ↗
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.
Distribution
Distributed to MI, KS, and CA.
Lot / Code Info
PMA #N17755, decision date 5/17/1976, reclassified 10/14/1999. Class II device; D033511, Item No. 00-1101-012-00; lot 62849791, 14D0809, Manufactured between 9/11/2014-10/6/2014; EXP date: 4/30/2017
Root Cause
Employee error
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.