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U.S. Department of Health and Human Services

Class 2 Device Recall Scorpio Fixed Femoral A/P Sizing Guide

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 Class 2 Recall
Scorpio Fixed Femoral A/P Sizing Guide
see related information
Date Posted January 19, 2011
Recall Status1 Terminated on July 31, 2013
Recall Number Z-0928-2011
Recall Event ID 56931
Product Classification Orthopedic Manual Surgical Instrument - Product Code LXH
Product Scorpio Fixed Femoral A/P Sizing Guide; non-sterile instruments; Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ 07430; A subsidiary of Stryker Corporation The A/P sizer is designed to set the desired external rotation and to provide adjustment of the anterior/posterior position when needed.
Code Information Catalog Number 8001-0313 Lot # RD3N198 & Lot #RD3N200
Recalling Firm/
Manufacturer
Stryker Howmedica Osteonics Corp.
325 Corporate Drive
Mahwah, New Jersey 07430
For Additional Information Contact Ms. Colleen O'Meara
201-831-5970
Manufacturer Reason
for Recall
Stryker Orthopaedics has become aware that there is a potential for the shoulder screw on the Scorpio Sizing Guide (the "Sizing Guide") to disassociate from the main body of the instrument.
FDA Determined
Cause 2
DESIGN: Component Design/Selection
Action Stryker Orthopaedics sent an 'Urgent Update Product Recall' letter dated December 30, 2010, along with Product Acknowledgement forms to all customers (US and international). The letter described the product, problem and action to be taken by the customers. The customers were asked to complete and return the PRODUCT RECALL ACKNOWLEDGMENT FORM within five (5) days via fax at 201-831-6069; contact the hospitals in their territory that have the affected product to arrange return of the product; and return the affected product to the attention of Regulatory Compliance, Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. If you have any questions, feel free to contact the Manager, Divisional Regulatory Compliance at (201) 972-2100 or the Associate Product Manager, Knee Marketing Team, at (201) 831-5028.
Quantity in Commerce six units
Distribution Worldwide distribution: USA and countries including: Australia, Brazil, China, Columbia, France, Greece, India, Italy, Korea, Poland, Singapore, South Africa, and United Kingdom.
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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