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U.S. Department of Health and Human Services

Class 2 Device Recall MTF Cortical Pin

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  Class 2 Device Recall MTF Cortical Pin see related information
Date Initiated by Firm May 27, 2015
Date Posted July 24, 2015
Recall Status1 Terminated 3 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
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 2		 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 and Original Applicant = MUSCULOSKELETAL TRANSPLANT FOUNDATION
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