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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 Prosthesessee related information
Date Initiated by FirmDecember 26, 2002
Date PostedFebruary 25, 2003
Recall Status1 Terminated 3 on April 22, 2003
Recall NumberZ-0567-03
Recall Event ID 25395
510(K)NumberK953977 
ProductHip Prosthesis as a component of Primaloc Cementless/Collarless Hip System
Code Information Catalog # 111-0917, Lot # OD-22372. Catalog # 111-1015, Lot # OD-21589, OD-21589-1 Catalog # 111-1017, Lot # OD-23209. Catalog # 111-1019, Lot # OD-23235. Catalog # 111-1115, Lot # OD-22050. Catalog # 111-1117, Lot # OD-23205, OD-23205-1, OD-23298. Catalog # 111-1119, Lot # OD-22846, W002952, OD-23222. Catalog # 111-1217, Lot # OD-23207, OD-23208, OD-23299. Catalog # 111-1219, Lot # OD-22847, OD-20859-1, OD-23230, OD-22847-1. Catalog # 111-1221, Lot # OD-23254, OD-23249, Catalog # 111-1223, Lot # OD-18165, W002524. Catalog # 111-1319, Lot # OD-23231, OD-23231-1.  Catalog # 111-1321, Lot # OD-23247. Catalog # 111-1421, Lot # OD-23250, OD-23255. Catalog # 111-1423, Lot # OD-23256. Catalog # 111-1425, Lot # OD-20837-1, W002683. Catalog # 111-1625, Lot # OD-21873, OD-19626-1, OD-22537.
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
ActionConsignees were notified on 12/26/2002 via telephone and e-mail.
Quantity in Commerce105
DistributionTX 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) Database510(K)s with Product Code =
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