Date Initiated by Firm | February 20, 2008 |
Date Posted | August 20, 2008 |
Recall Status1 |
Terminated 3 on September 02, 2008 |
Recall Number | Z-1539-2008 |
Recall Event ID |
46960 |
510(K)Number | K020114 |
Product Classification |
Knee Prosthesis - Product Code JWH
|
Product | 3DKNEE Tibial Insert Trial, Size 2, 13mm Right; Part #801-01-640; manufactured by Encore Medical, L.P., Austin, TX 78758.
Used in surgery to determine the correct size of 3DKnee component to implant that would allow for the best range of motion and joint stability. |
Code Information |
Lot #53906407 |
Recalling Firm/ Manufacturer |
Encore Medical, Lp 9800 Metric Blvd Austin TX 78758
|
For Additional Information Contact | 512-832-9500 |
Manufacturer Reason for Recall | Tibial insert trial incorrectly marked for thickness; device thickness marked correctly as 13mm on the underside of the trial, but is incorrectly marked as 15mm on the side. |
FDA Determined Cause 2 | Error in labeling |
Action | Firm notified consignee by phone and asked them to return any outstanding product on 02/20/08. |
Quantity in Commerce | 6 units. |
Distribution | Distribution --- country of Germany. |
Total Product Life Cycle | TPLC Device Report |
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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 = JWH
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