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Class 2 Device Recall Hip Prostheses |
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Date Initiated by Firm |
December 26, 2002 |
Date Posted |
February 25, 2003 |
Recall Status1 |
Terminated 3 on April 22, 2003 |
Recall Number |
Z-0567-03 |
Recall Event ID |
25395 |
510(K)Number |
K953977
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Product |
Hip 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
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Manufacturer Reason for Recall |
Cleaning agent residue from packaging material was adhering to implantable hip stems.
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FDA Determined Cause 2 |
Other |
Action |
Consignees were notified on 12/26/2002 via telephone and e-mail. |
Quantity in Commerce |
105 |
Distribution |
TX and Japan |
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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.
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510(K) Database |
510(K)s with Product Code = and Original Applicant = ORTHO DEVELOPMENT CORP.
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