Z-2075-2015 Class II Terminated
FDA device recall Z-2075-2015 was initiated by Musculoskeletal Transplant Foundation, Inc. on May 27, 2015 and is designated Class II. 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. The recall status is terminated (terminated May 8, 2017). Affected quantity: 117 units.
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