|
Class 2 Device Recall Scorpio |
|
Date Initiated by Firm |
April 05, 2010 |
Date Posted |
August 02, 2010 |
Recall Status1 |
Terminated 3 on August 28, 2012 |
Recall Number |
Z-2119-2010 |
Recall Event ID |
55357 |
Product Classification |
knee prosthesis instrument - Product Code LXH
|
Product |
X-Celerate Instrumentation Punch Thru Tibial Base Plate, Catalog numbers: 3750-0003. 3750-0004, 3750-0005, 3740-0006, 3750-0007, 3750-0009, 3750-0011, 3750-0013; Stryker Howmedica Osteonics Corp Scorpio Total Knee System
|
Code Information |
Catalog numbers: 3750-0003. 3750-0004, 3750-0005, 3740-0006, 3750-0007, 3750-0009, 3750-0011, 3750-0013; All lots. |
Recalling Firm/ Manufacturer |
Stryker Howmedica Osteonics Corp. 325 Corporate Drive Mahwah NJ 07430
|
For Additional Information Contact |
Colleen O'Meara 201-831-5970
|
Manufacturer Reason for Recall |
The locating pins on the Punch Thru Tibial Baseplates could break or disassociate from the main body of the instrument.
|
FDA Determined Cause 2 |
Device Design |
Action |
Stryker Urgent Device Correction letters dated April 5, 2010, were sent to all Stryker branches/agencies, hospital Risk Management and surgeons who have used the product by Federal Express. Questions on the bulletin should be directed to Scott Solis, Product Manager ,Knee Marketing at 201-831-5665. |
Quantity in Commerce |
8276 |
Distribution |
Worldwide distribution: USA, China, Taiwan, India, Australia, Korea, Singapore, Germany, France, Spain, Italy, Switzerland, Poland, Romania, South Africa, United Kingdom, Netherlands, Sweden, Turkey, Japan, Chile, Brazil, Colombia, Mexico, Panama, Argentina, and Uruguay. |
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.
|
|
|
|