NeoSpan SuperElastic Compression Staple w/Instruments, Size 10x10x10, Part Number T50 SN010
FDA Recall Z-0670-2019 · Posted None
Recalling FirmIn2bones USA, LLC
Recall StatusTerminated
Product CodeJDR
Date Initiated2018-11-14
Date Terminated2019-05-08
Product Quantity30 units
Reason for Recall
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.
Firm Action
The firm initiated the recall by letter on 11/14/2018. The letter requested the return of the product.
Root Cause
Employee error
Distribution Pattern
TX, VA, PA, MO, NJ, FL, TN, NC, OH, WI, LA
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.