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U.S. Department of Health and Human Services

Class 2 Device Recall RETiLOCK

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  Class 2 Device Recall RETiLOCK see related information
Date Initiated by Firm September 30, 2003
Date Posted July 20, 2004
Recall Status1 Terminated 3 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 2
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 and Original Applicant = SULZER ORTHOPEDICS, INC.
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