|
Class 2 Device Recall Foundation Hip System Bipolar Modular |
|
Date Initiated by Firm |
August 02, 2007 |
Date Posted |
November 07, 2007 |
Recall Status1 |
Terminated 3 on January 09, 2008 |
Recall Number |
Z-0092-2008 |
Recall Event ID |
44788 |
510(K)Number |
K953510
|
Product Classification |
hip prosthesis - Product Code KWY
|
Product |
Foundation¿ Hip System Bipolar Modular, Size 50mm OD; Cat. #412-01-050; Sterile; assembly required by physician prior to implant; manufactured by Encore Medical, L.P., Austin, TX 78758. |
Code Information |
Lot #: 624401, 676821, 677141, 677611, 678831, 678841, 678851, 678861, 678871, 695171, 633831, 733831, 734561, 738471, 738481, 738491, 770151, 777471, 778441, 778451, 788531, 788541, 814371, 830961, 840341, 840351, 840361, 844621, 854641, 854651, 855001, 857801, 894261, 894271, 905631, 905641, 905651, 907241, 933881, 933891, 949521, 949531, 958961, 964431, 964441 and 964451. |
Recalling Firm/ Manufacturer |
Encore Medical, Lp 9800 Metric Blvd Austin TX 78758
|
For Additional Information Contact |
512-834-6235
|
Manufacturer Reason for Recall |
Device mislabeled; hip prosthesis components validated for 5 years were labeled as having a 6 year expiration date.
|
FDA Determined Cause 2 |
Packaging change control |
Action |
Firm notified consignees of recall via phone, e-mail and overnight letters beginning on 08/02/07. Consignees asked to return devices for a properly labeled replacement. |
Quantity in Commerce |
225 units. |
Distribution |
Worldwide, including USA, Greece, Japan, and Saudi Arabia. |
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 = KWY and Original Applicant = ENCORE ORTHOPEDICS, INC.
|
|
|
|