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U.S. Department of Health and Human Services

Class 2 Device Recall Absolute shoulder

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  Class 2 Device Recall Absolute shoulder see related information
Date Initiated by Firm February 23, 2004
Date Posted July 20, 2004
Recall Status1 Terminated 3 on April 13, 2004
Recall Number Z-0777-04
Recall Event ID 28433
510(K)Number K002998  
Product Classification Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented - Product Code KWT
Product Biomet brand Absolute Bi-Polar Shoulder Shell 48 mm w/locking ring; part 113156.
Code Information lot 551440.
Recalling Firm/
Biomet, Inc.
56 E Bell Dr
Warsaw IN 46582-6989
For Additional Information Contact Paula Hoesel
800-348-9500 Ext. 1305
Manufacturer Reason
for Recall
The locking ring was not included and the shoulder implanted without the locking ring.
FDA Determined
Cause 2
Action The firm recovered the consigneed units from hospital stocks and issued a letter dated 2/23/04 to the two implanting physicians.
Quantity in Commerce 7
Distribution California, Florida, Washington, Germany and Venezuela.
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 = KWT and Original Applicant = BIOMET, INC.