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.
This recall has been terminated (originally issued July 15, 2015).
- Recall Initiated
- May 27, 2015
- Posted
- July 15, 2015
- Terminated
- May 8, 2017
- Recall Number
- Z-2075-2015
- Quantity
- 117 units
- Firm Location
- Edison, NJ
- Official Source
- View on FDA website ↗
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
US Nationwide Distribution in the states of AZ, CA, CO, FL, IL, MI, MN, NC, NJ, NV, PA, TN, TX, UT, WA and WV.
Lot / Code Info
Product Code: 900920, Serial #:906912041001, Expiry date 01Mar2017
Root Cause
Process control
Action Taken
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.