CLASS II Device recall · Reported 2 Jan 2019 · FDA Enforcement Report

NeoSpan SuperElastic Compression Staple w/Instruments, Size 10x10x10 recalled

In2bones USA is recalling NeoSpan SuperElastic Compression Staple w/Instruments, Size 10x10x10, distributed in 11 states. The recall was initiated on 14 Nov 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot Number: 9G88C0

Quantity recalled30 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0670-2019
FDA event ID: 81655
Recalling firm: In2bones USA, Memphis, TN
Classification: Class II
Status: Terminated
Recall initiated: 14 Nov 2018
FDA classified: 22 Dec 2018
Reported: 2 Jan 2019
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

14 Nov 2018	Recall initiated by company
22 Dec 2018	Classified by FDA	+38 days
2 Jan 2019	Published in enforcement report	+11 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

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

Where it was distributed

TX, VA, PA, MO, NJ, FL, TN, NC, OH, WI, LA

Florida Louisiana Missouri North Carolina New Jersey Ohio Pennsylvania Tennessee Texas Virginia Wisconsin

Questions about this recall

Why was it recalled?

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.

Which lots are affected?

Lot Number: 9G88C0

Where was it sold?

TX, VA, PA, MO, NJ, FL, TN, NC, OH, WI, LA

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from In2bones USA

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Reported	Class	Recall	Company	Reason	Where
17 Jun 2026Device	CLASS II	NeoSpan¿ SuperElastic Compression Staple w/Instruments recalled	In2bones USA	Foreign Material	25 states
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