Device 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.
Z-2075-2015
Product summary
- Event
- Event 71559
- Status
- Terminated
- Classification
- Class II
- Quantity
- 117 units
- Official record key
device-enforcement:Z-2075-2015
Official wording
Reason: 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.
Code information: Product Code: 900920, Serial #:906912041001, Expiry date 01Mar2017
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.
Derived failure modes
-
Unknown
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.