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U.S. Department of Health and Human Services

Class 2 Device Recall Musculoskeletal Transplant Foundation Allofix Insertion Kit

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  Class 2 Device Recall Musculoskeletal Transplant Foundation Allofix Insertion Kit see related information
Date Initiated by Firm May 27, 2015
Date Posted July 15, 2015
Recall Status1 Terminated 3 on May 08, 2017
Recall Number Z-2075-2015
Recall Event ID 71559
Product Classification Brace, drill - Product Code HXY
Product Allofix Insertion Kit, 2.0 mm, Single Drill,

Product Usage:
MTF Surgical Instruments are designed for the specific needs of the orthopedic surgeon and are intended to be used in conjunction with the associated allograft. This kit is for single use only.
Code Information Product Code: 900920, Serial #:906912041001, Expiry date 01Mar2017
Recalling Firm/
Manufacturer		 Musculoskeletal Transplant Foundation, Inc.
125 May St Ste 300
Edison NJ 08837-3264
For Additional Information Contact MTF Customer Service Department
800-433-6576
Manufacturer Reason
for Recall		 Musculoskeletal Transplant Foundation is recalling a certain lot of Allofix Insertion Kits because they are labeled as having a 2.0mm diameter drill however it may contain a 2.4 mm diameter drill.
FDA Determined
Cause 2		 Process control
Action Musculoskeletal Transplant Foundation notified their affected customers of this recall by sending them a Voluntary Recall Notification Letter dated May 27, 2015 or via telephone. The letter identified the affected product, problem and actions to be taken. For questions contact Customer Service at 1-800-433-6576.
Quantity in Commerce 117 units
Distribution US Nationwide Distribution in the states of AZ, CA, CO, FL, IL, MI, MN, NC, NJ, NV, PA, TN, TX, UT, WA and WV.
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.
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