Z-0670-2019Class II

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

Name: Z-0670-2019 NeoSpan SuperElastic Compression Staple w/Instruments, Size 10x10x10, Part Number T50 SN010
Creator: In2bones USA, LLC
Published: 2018-11-14
License: https://open.fda.gov/license/

In2bones USA, LLC / initiated 2018-11-14 / Terminated / root cause: manufacturing process

FDA source

In2bones USA, LLC began a recall of NeoSpan SuperElastic Compression Staple w/Instruments, Size 10x10x10, Part Number T50 SN010 on 2018-11-14. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0670-2019
Classification: Class II
Status: Terminated
Initiated: 2018-11-14
Posted: 2018-12-22
Terminated: 2019-05-08
Recalling firm: In2bones USA, LLC
Product: NeoSpan SuperElastic Compression Staple w/Instruments, Size 10x10x10, Part Number T50 SN010
Product code: JDR Staple, Fixation, Bone
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.
Root cause tag: manufacturing process
FDA 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 in commerce: 30 units
Distribution: TX, VA, PA, MO, NJ, FL, TN, NC, OH, WI, LA
Product codes and lots: Lot Number: 9G88C0

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0670-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0670-2019	Class II	Terminated	Voluntary: Firm initiated	2019-01-02	2018-12-22

Product code JDR

K161426Class IINeoSpan Compression Staple Impant w/instrumentsIn2bones USA, LLC / cleared 2016-10-24

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)