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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-0568-03 |
| Recall Event ID |
25395 |
| 510(K)Number |
K962448
|
| Product |
Hip 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 |
| Action |
Consignees were notified on 12/26/2002 via telephone and e-mail. |
| Quantity in Commerce |
41 |
| 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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