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U.S. Department of Health and Human Services

Class 2 Device Recall Instratek Carpal Tunnel Release Blades

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  Class 2 Device Recall Instratek Carpal Tunnel Release Blades see related information
Date Initiated by Firm May 03, 2013
Date Posted July 01, 2013
Recall Status1 Terminated 3 on July 11, 2013
Recall Number Z-1623-2013
Recall Event ID 65205
Product Classification Knife, surgical - Product Code EMF
Product -Instratek Carpal Tunnel Release Blades, (1) Triangle Blade, (1) Hook Blade. REF R2056 - LOT 122279

-Instratek Carpal Tunnel Release Hook Blade. REF 2055 Lot 122669

-Linvatec CTS Relief Kit. REF 9971, lot 122504

-Biomet Indiana Tome Blade for Carpal Tunnel Release (White). REF 200060. Lot 122504 and Lot 123190.

-KMI SafeGuard Knife, For SafeGuard Mini Carpal Tunnel Release System, (White). REF 08-0003. Lot # 122609

Surgical Knife
Code Information 122279; 122493; 122504; 122609; 122669; 123190 
Recalling Firm/
Surgical Instrument Service And Savings, Inc.
2747 Sw 6th St
Redmond OR 97756-7109
For Additional Information Contact Rich Wynkoop
Manufacturer Reason
for Recall
The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch.
FDA Determined
Cause 2
Packaging process control
Action MEDISISS sent a Correction Immediate Action Request letter dated May 2, 2013, to all affected customes. The letter identified the product, the problem, and the action to be taken by the customer. The letter directed the customer to inspect the products prior to use for seal integrity as specified on the product labeling: "Sterile unless package has been damaged or opened. Do not use if package is damaged." This will be followed up by a visit from the customer's sales representatives who are tasked with inspecting all the lots that may be remaining in the customer's inventory. The sales representative is directed to complete a "Verification of Seal Inspection" form and return it to MEDISISS Customer Relations. Devices with unacceptable seals are to be returned to MEDISISS. The sales representative is responsible for obtaining a shipping label from customer service to enable the devices to be returned to the recalling firm via Fed Ex. Customers with questions were instructed to call 866-866-7477.
Quantity in Commerce 56 units
Distribution Nationwide Distribution.
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.