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U.S. Department of Health and Human Services

Class 2 Device Recall Osteobond Copolymer Bone Cement

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  Class 2 Device Recall Osteobond Copolymer Bone Cement see related information
Date Initiated by Firm December 08, 2014
Date Posted December 31, 2014
Recall Status1 Terminated 3 on July 17, 2015
Recall Number Z-0900-2015
Recall Event ID 69904
Product Classification Bone cement - Product Code LOD
Product Osteobond Bone Cement

Bone cement monomer is kitted with bone cement powder to create a cement mantle for orthopedic implants.
Code Information 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
Recalling Firm/
Manufacturer		 Zimmer, Inc.
1800 W Center St
Warsaw IN 46580-2304
For Additional Information Contact Consumer Relations Call Center
800-447-5633
Manufacturer 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.
FDA Determined
Cause 2		 Employee error
Action "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.
Quantity in Commerce 40 units
Distribution Distributed to MI, KS, and CA.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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