Date Initiated by Firm |
April 12, 2007 |
Date Posted |
July 23, 2007 |
Recall Status1 |
Terminated 3 on July 25, 2007 |
Recall Number |
Z-1063-2007 |
Recall Event ID |
37881 |
510(K)Number |
K000817
|
Product Classification |
Hip replacement prosthesis component - Product Code JDI
|
Product |
ALFA II Modular Femoral Revision Stem Porous Coated; Size 6; Length: 200mm; Diameter:18.0mm; Catalog #651-06-180; component of the ENCORE Hip System; Single Use, Sterile; distributed by Encore Medical, L.P., Austin, TX 78758. |
Code Information |
Lot # Y031E. |
Recalling Firm/ Manufacturer |
Encore Medical, Lp 9800 Metric Blvd Austin TX 78758
|
Manufacturer Reason for Recall |
Sterility/Package Integrity : Device packaging may potentially be unable to ensure sterility when exposed to shipping conditions.
|
FDA Determined Cause 2 |
Other |
Action |
Urgent Device Recall Notification letters distributed to consignees on 04/14/07. Consignees requested to return product to Encore Medical, L.P. |
Quantity in Commerce |
3 units. |
Distribution |
Product distributed to surgical centers in CT, KS and MO. |
Total Product Life Cycle |
TPLC Device Report
|
|
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 = JDI and Original Applicant = OSTEOIMPLANT TECHNOLOGY, INC.
|