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U.S. Department of Health and Human Services

Class 2 Device Recall Scorpio

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 Class 2 Recall
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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/
Stryker Howmedica Osteonics Corp.
325 Corporate Drive
Mahwah, New Jersey 07430
For Additional Information Contact Colleen O'Meara
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.