Date Initiated by Firm |
June 30, 2008 |
Date Posted |
September 17, 2008 |
Recall Status1 |
Terminated 3 on January 05, 2009 |
Recall Number |
Z-2299-2008 |
Recall Event ID |
48715 |
510(K)Number |
K033634
|
Product Classification |
hip implant component - Product Code KWA
|
Product |
Zimmer Metasul Head 32/-4'S', taper 12/14, hip implant component; REF 19.32.05. |
Code Information |
Lot 2299218. |
Recalling Firm/ Manufacturer |
Zimmer Inc. 345 E Main St Warsaw IN 46580-2746
|
For Additional Information Contact |
574-372-4487
|
Manufacturer Reason for Recall |
The wrong part may be in the package. Package may contain a 28 mm head.
|
FDA Determined Cause 2 |
Packaging process control |
Action |
Zimmer notified consignees via recall letter dated 6/20/08 to return the product. |
Quantity in Commerce |
4 |
Distribution |
Florida, Pennsylvania, Texas and Virginia. |
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 = KWA and Original Applicant = CENTERPULSE ORTHOPEDICS, INC.
|