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U.S. Department of Health and Human Services

Class 2 Device Recall Hip Prostheses

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  Class 2 Device Recall Hip Prostheses see related information
Date Initiated by Firm December 26, 2002
Date Posted February 25, 2003
Recall Status1 Terminated 3 on April 22, 2003
Recall Number Z-0566-03
Recall Event ID 25395
510(K)Number K953977  
Product Hip Prosthesis as a component of Primaloc Cementless/Collared Hip System.
Code Information Catalog # 112-0915, Lot # OD-18031, W003152, WO#003152. Catalog # 112-0917, Lot # OD-19103-1, OD-20567, W0#003109. Catalog # 112-1015, Lot # OD-19038, W0#003155. Catalog # 112-1017, Lot # OD-17403. Catalog # 112-1115, Lot # WO#003045. Catalog # 112-1117, Lot # OD-23210, OD-23211. Catalog # 112-1119, Lot # OD-23232. Catalog # 112-1217, Lot # OD-23206. Catalog # 112-1219, Lot # OD-23233. Catalog # 112-1221, Lot # OD-23252 Catalog # 112-1223, Lot # OD-17321, W003725, WO#003350. Catalog # 112-1319, Lot # OD-20572, OD-20867-1, OD-23234, OD-23234-1, OD-23246. Catalog # 112-1321, Lot # OD-23253. Catalog # 112-1421, Lot # OD-23248, OD-23248-1, OD-23251, OD-23251-1. Catalog # 112-1425, Lot # OD-21874. Catalog # 112-1623, Lot # OD-21147-1. Catalog # 112-1625, Lot # W0#003130, WO#003139.
Recalling Firm/
Manufacturer		 Ortho Development Corporation
12187 Business Park Drive
Draper UT 84020
Manufacturer Reason
for Recall		 Cleaning agent residue from packaging material was adhering to implantable hip stems.
FDA Determined
Cause 2		 Other
Action Consignees were notified on 12/26/2002 via telephone and e-mail.
Quantity in Commerce 78
Distribution TX and Japan
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 = and Original Applicant = ORTHO DEVELOPMENT CORP.
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