Class 2 Device Recall

• Date Initiated by Firm: June 18, 2003
• Date Posted: September 24, 2003
• Recall Status: Terminated on September 23, 2003
• Recall Number: Z-1281-03
• Recall Event ID: 26618
• 510(K)Number: K911684
• Product Classification: Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented - Product Code JDI
• Product: Stanmore modular hip system; Stanmore CoCr femoral size 1 std. stem; part 164241
• Code Information: lots 323846, 342260, 352799, 377954, 404867, 434003, 442086, 442087, 442088, 448410, 469963, 469966
• Recalling Firm/ Manufacturer: Biomet, Inc.; 56 East Bell Drive; Warsaw IN 46582
• For Additional Information Contact: 800-348-9500 Ext. 1305
• Manufacturer Reason for Recall: The labeling does not instruct the removal of the protective shipping cap, and one surgeon implanted with the cap still in place.
• FDA Determined Cause: Other
• Action: Distributors were sent a letter on June 18, 2003 via FedEx. This mailing contained labels and the distributors were instructed to affix the label to the inventory consigned to hospitals within their territory.
• Quantity in Commerce: 16
• Distribution: United States
• 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 = JDI