Allofix Insertion Kit, 2.0 mm, Single Drill, Product Usage: MTF Surgical Instruments are designed for the specific needs
FDA device recall Z-2075-2015 · posted 2015-07-15 · Terminated
Recall details
- Recalling firm
- Musculoskeletal Transplant Foundation, Inc.
- 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.
- 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.
- Root cause
- Process control
- Status
- Terminated
- Product code
- HXY
- Quantity affected
- 117 units
- 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.
- Date initiated
- 2015-05-27
- Date posted
- 2015-07-15
- Date terminated
- 2017-05-08
- Location
- Edison, NJ
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