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U.S. Department of Health and Human Services

Class 2 Device Recall IMHS CP

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 Class 2 Recall
IMHS CP
see related information
Date Posted August 04, 2009
Recall Status1 Open
Recall Number Z-1704-2009
Recall Event ID 52177
Premarket Notification
510(K) Number
Product Classification Orthopedic Manual Surgical Instrument - Product Code LXH
Product IMHS CP, 3.2mm, Tip Threaded Guide Pin, REF71687000, for use with IntraMedullary Hip Screw in orthopedic surgery.
Code Information Lot Number: 08K22270
Recalling Firm/
Manufacturer
Smith & Nephew Inc
1450 E. Brooks Rd
Memphis, Tennessee 38116
Consumer Instructions Contact the recalling firm for information
For Additional Information Contact Victor Rocha
901-396-2121 Ext. 5373
Manufacturer Reason
for Recall
Incorrect depth gauge mark etched onto guide wire pin. Guide pin is too long.
FDA Determined
Cause 2
DESIGN: Process Design
Action Urgent Medical Device Recall letter dated January 23, 2009. All affected Smith & Nephew Sales Representatives, Distributors and Hospitals were notified of problem and the recall via Fed Ex and e-mail on 01/22/2009. They were instructed to immediately check their inventory and return the product.
Quantity in Commerce 99 units
Distribution Distribution to USA, Switzerland and Australia.
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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