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U.S. Department of Health and Human Services

Class 2 Device Recall Scorpio

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 Class 2 Recall
Scorpio
see related information
Date Posted August 02, 2010
Recall Status1 Terminated on August 28, 2012
Recall Number Z-2119-2010
Recall Event ID 55357
Product Classification Orthopedic Manual Surgical 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, New Jersey 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
DESIGN: 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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