Device product
NeoSpan SuperElastic Compression Staple w/Instruments, Size 10x10x10, Part Number T50 SN010
Z-0670-2019
Product summary
- Event
- Event 81655
- Status
- Terminated
- Classification
- Class II
- Quantity
- 30 units
- Official record key
device-enforcement:Z-0670-2019
Official wording
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.
Code information: Lot Number: 9G88C0
Distribution pattern: TX, VA, PA, MO, NJ, FL, TN, NC, OH, WI, LA
Derived failure modes
-
Unknown
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.