FDA-Device2019-01-02Class II

NeoSpan SuperElastic Compression Staple w/Instruments, Size 10x10x10, Part Number T50 SN010

In2bones USA, LLC
Hazard

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.

Sold states
TX, VA, PA, MO, NJ, FL, TN, NC, OH, WI, LA
Affected count
30 units
Manufactured in
6060 Poplar Ave Ste 380, Memphis, TN, United States
Products
NeoSpan SuperElastic Compression Staple w/Instruments, Size 10x10x10, Part Number T50 SN010

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0670-2019

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