—#131930

Product

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

FDA product code: LOD — Bone Cement
Device class: Class 2
Medical specialty: Orthopedic
Affected 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

Why it was recalled

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.

Root cause (FDA determination)

Employee error

Action the firm took

"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.

Recalling firm

Firm: Zimmer, Inc.
Address: 1800 W Center St, Warsaw, Indiana 46580-2304

Distribution

Distribution pattern: Distributed to MI, KS, and CA.

Timeline

Recall initiated: 2014-12-08
Posted by FDA: 2014-12-31
Terminated: 2015-07-17
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #131930. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.