Z-2075-2015 Class II Terminated

Recalled by Musculoskeletal Transplant Foundation, Inc. — Edison, NJ

Recall Details

Product Type
Devices
Report Date
July 22, 2015
Initiation Date
May 27, 2015
Termination Date
May 8, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
117 units

Product Description

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.

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.

Distribution Pattern

US Nationwide Distribution in the states of AZ, CA, CO, FL, IL, MI, MN, NC, NJ, NV, PA, TN, TX, UT, WA and WV.

Code Information

Product Code: 900920, Serial #:906912041001, Expiry date 01Mar2017