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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-0568-03
Recall Event ID 25395
510(K)NumberK962448 
ProductHip Prosthesis as a component of Primaloc Cemented Hip System.
Code Information Catalog # 114-0917, Lot # OD-18030-5, W003600, W003601, W003602. Catalog # 114-1017, Lot # OD-18563, OD-18563-1, OD-23190, OD-23191, OD-23221. Catalog # 114-1219, Lot # OD-23192, OD-23192-1, OD-23193, OD-23194. Catalog # 114-1421, Lot # OD-17306, OD-17412. Catalog # 114-1623, Lot # W0#003264, W003614.
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 Commerce41
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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