Class 2 Device Recall MTF Cortical Pin

• Date Initiated by Firm: May 27, 2015
• Date Posted: July 24, 2015
• Recall Status: Terminated on December 17, 2015
• Recall Number: Z-2210-2015
• Recall Event ID: 71564
• 510(K)Number: K061498
• Product Classification: Pin, fixation, threaded - Product Code JDW
• Product: Cortical Pin 2.0 mm,Sterile, FREEZE DRIED: Store at ambient temperature. Do Not freeze.
• Code Information: Lot #06512078901017, Item #400920. The tissue is placed in a retainer and sealed in a blister pack
• FEI Number: 3001236616
• Recalling Firm/ Manufacturer: Musculoskeletal Transplant Foundation, Inc.; 125 May St Ste 300; Edison NJ 08837-3264
• For Additional Information Contact: MFT Customer Service Department; 800-433-6576
• Manufacturer Reason for Recall: Musculoskeletal Transplant Foundation (MTF) is recalling one lot of MTF's Allograft Cortical Pins because the lot was labeled as a 2.0 mm diameter pin and it may contain a 2.4 mm diameter pin.
• FDA Determined Cause: Labeling mix-ups
• Action: Musculoskeletal Transplant Foundation initiated this recall by either telephoning their customers or by sending a recall letter dated 5/27/15 to the customer.
• Quantity in Commerce: 22 units
• Distribution: Distributed in the states of AZ, CO, MI, MN, NC, OH and TX.
• 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.

• 510(K) Database: 510(K)s with Product Code = JDW