Class 2 Device Recall RETiLOCK

• Date Initiated by Firm: September 30, 2003
• Date Posted: July 20, 2004
• Recall Status: Terminated on November 04, 2004
• Recall Number: Z-0809-04
• Recall Event ID: 28512
• 510(K)Number: K022985
• Product Classification: Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented - Product Code LZO
• Product: RETi-LOCK Cluster-Hole Acetabular Shells with Sealed Screw-holes manufactured by Zimmer, Austin, Texas
• Code Information: Lot numbers: 1548942, 1548943, 1548944, 1548947, 1548948, 1548949, 1548950, 1553246, 1553248, 1553251, 1553252, 1553254, 1553259, 1553261, 1553262, 1553265, 1553266, 1553268, and 1553269
• Recalling Firm/ Manufacturer: Centerpulse Orthopedics, Inc; 9900 Spectrum Dr; Austin TX 78717-4555
• Manufacturer Reason for Recall: Compalints of acetabular shell disassociating with the bone.
• FDA Determined Cause: Other
• Action: The firm called and issued letters on September 30, 2003 informing physicians of a complaint received. The letter requested that the physicians discontinue use of the device until and investigation could be conducted. On 03/8/2004 the firm issued a letter to Zimmer distributors to return all inventory.
• Quantity in Commerce: 145 units
• Distribution: Physicians in the following areas: CA, Washington D.C., MD, LA, ID, and WA
• 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 = LZO