Class 2 Device Recall Absolute shoulder

• Date Initiated by Firm: February 23, 2004
• Date Posted: July 20, 2004
• Recall Status: Terminated 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/ Manufacturer: 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: Other
• 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