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U.S. Department of Health and Human Services

Class 2 Device Recall Zimmer Anatomical Shoulder Glenoid

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  Class 2 Device Recall Zimmer Anatomical Shoulder Glenoid see related information
Date Initiated by Firm June 25, 2007
Date Posted August 23, 2007
Recall Status1 Terminated 3 on December 05, 2007
Recall Number Z-1194-2007
Recall Event ID 38462
510(K)Number K990136  
Product Classification Shoulder prosthesis component - Product Code KWS
Product Zimmer Anatomical Shoulder Prosthesis, Glenoid, Cemented, sterile; REF 01.04214.370.
Code Information Lot 2385941.
Recalling Firm/
Manufacturer		 Zimmer Inc.
1800 W Center St
Warsaw IN 46580-2304
For Additional Information Contact
800-846-4637
Manufacturer Reason
for Recall		 The package actually contains a knee patellar implant.
FDA Determined
Cause 2		 Other
Action The firm notifed the distributor via letter dated 6/25/07, and sent by email, to retrieve the product from their customers and to return the product.
Quantity in Commerce 10
Distribution Maryland.
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.
510(K) Database 510(K)s with Product Code = KWS and Original Applicant = SULZER ORTHOPEDICS, INC.
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