Date Initiated by Firm |
June 16, 2006 |
Date Posted |
July 27, 2006 |
Recall Status1 |
Terminated 3 on December 05, 2007 |
Recall Number |
Z-1274-06 |
Recall Event ID |
35783 |
Product Classification |
shoulder prosthesis instrument - Product Code HWT
|
Product |
Zimmer Trabecular Metal Shoulder Instrumentation Distal Pilot, 11 mm diameter, 130 mm length, non-sterile, catalog no. 4309-11-13 (00-4309-011-13). |
Code Information |
All lots. |
Recalling Firm/ Manufacturer |
Zimmer Inc. 345 E Main St Warsaw IN 46580-2746
|
For Additional Information Contact |
800-846-4637
|
Manufacturer Reason for Recall |
During provisional trialing, the instrument may become stuck in the humeral canal and require surgical removal.
|
FDA Determined Cause 2 |
Other |
Action |
U.S. and international distributors were notified of the recall via letter dated 6/30/2006 to check customer inventories and to return recalled product to the firm. Trial implants were redesigned and reworked to eliminate the problem. |
Quantity in Commerce |
324 total |
Distribution |
Nationwide and worldwide including Australia, Canada, Germany, Italy and Spain. |
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.
|