FDA Medical Device Recalls (openFDA)
In2bones USA, LLC: NeoSpan SuperElastic Compression Staple w/Instruments, Size 10x10x10, Part Number T50 SN010
- Recall number
- Z-0670-2019
- Recalling firm
- In2bones USA, LLC
- Product
- NeoSpan SuperElastic Compression Staple w/Instruments, Size 10x10x10, Part Number T50 SN010
- Status
- Terminated
- Initiated
- 2018-11-14
- Posted
- not on file
- Terminated
- 2019-05-08
- 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.
- Root cause
- Employee error
- Action
- The firm initiated the recall by letter on 11/14/2018. The letter requested the return of the product.
- Quantity
- 30 units
- Distribution
- TX, VA, PA, MO, NJ, FL, TN, NC, OH, WI, LA
- Lot, serial or model codes
- Lot Number: 9G88C0
- 510(k) numbers
- ["K161426"]
- PMA numbers
- not on file
- Product code
- JDR
- Firm FEI
- 3011580264
- Firm city
- Memphis
- Firm state
- TN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28