FDA Recall
Terminated
NeoSpan SuperElastic Compression Staple w/Instruments, Size 10x10x10, Part Number T50 SN010
Recall: Z-0670-2019
·
Initiated November 14, 2018
Recall
- Recall Number
- Z-0670-2019
- Event Number
- 81655
- Firm
- In2bones USA, LLC
- FEI Number
- 3011580264
- Product Code
- JDR
- Status
- Terminated
- Root Cause
- Employee error
- Initiated
- November 14, 2018
- Terminated
- May 8, 2019
- Address
- 6060 Poplar Ave, Ste 380, Memphis, TN, 38119-3915
Description
NeoSpan SuperElastic Compression Staple w/Instruments, Size 10x10x10, Part Number T50 SN010
Reason
The NeoSpan Compression Staple (10x10x10) kits from two lots contain the wrong size drill bit. They contain a 3mm drill bit instead of a 2mm drill bit.
Action
The firm initiated the recall by letter on 11/14/2018. The letter requested the return of the product.
Distribution
TX, VA, PA, MO, NJ, FL, TN, NC, OH, WI, LA
Quantity
30 units