FDA Enforcement
Class II
Terminated
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.
Recall: Z-2075-2015
·
Reported July 22, 2015
Enforcement
- Recall Number
- Z-2075-2015
- Event ID
- 71559
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Musculoskeletal Transplant Foundation, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Report Date
- July 22, 2015
- Initiation Date
- May 27, 2015
- Classification Date
- July 15, 2015
- Termination Date
- May 8, 2017
- Address
- 125 May St Ste 300, N/A, Edison, NJ, 08837-3264, United States
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
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 Info
Product Code: 900920, Serial #:906912041001, Expiry date 01Mar2017
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.
Quantity
117 units