Date Initiated by Firm |
December 07, 2006 |
Date Posted |
February 27, 2007 |
Recall Status1 |
Terminated 3 on July 11, 2012 |
Recall Number |
Z-0522-2007 |
Recall Event ID |
37005 |
510(K)Number |
K933494
|
Product Classification |
knee prosthesis - Product Code JWH
|
Product |
Polyethylene tibial posterior stabilized components. Optetrak All Poly Tibial PS Component. Knee prosthesis. Catalog number : 204-11-13 |
Code Information |
serial numbers: 0900529-0900532 |
Recalling Firm/ Manufacturer |
Exactech, Inc. 2320 NW 66th Ct Gainesville FL 32653-1630
|
Manufacturer Reason for Recall |
The outside profile on this manufactured lot of devices is oversized and does not meet specifications.
|
FDA Determined Cause 2 |
Other |
Action |
Letter dated 12/08/06. The firm representative retrieved all four devices from the field. |
Quantity in Commerce |
4 units |
Distribution |
Distributed to one hospital in New York. |
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 = JWH and Original Applicant = EXACTECH, INC.
|