The Recall Desk
ModerateFDA (Devices)·Z-0670-2019·Announced 2019-01-02

In2bones Recalls NeoSpan Compression Staple Kits Due to Incorrect Drill Bit Size

In2bones USA, LLC is recalling NeoSpan SuperElastic Compression Staple kits because they contain a 3mm drill bit instead of the required 2mm bit.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II. The hazard involves an incorrect component size (3mm vs 2mm drill bit) which poses a risk of improper use or injury, but no specific injuries or illnesses are reported in the source text.

Plain-English summary

In2bones USA, LLC is recalling 30 units of NeoSpan SuperElastic Compression Staple w/Instruments, Size 10x10x10, Part Number T50 SN010. The recall affects Lot Number 9G88C0.

The recall was initiated because the kits contain the wrong size drill bit. Specifically, the kits include a 3mm drill bit instead of the correct 2mm drill bit.

The affected products were distributed in Texas, Virginia, Pennsylvania, Missouri, New Jersey, Florida, Tennessee, North Carolina, Ohio, Wisconsin, and Louisiana. Consumers and healthcare providers should stop using the affected kits and contact the manufacturer for instructions on return or replacement.

The recalled product

Product
NeoSpan SuperElastic Compression Staple w/Instruments, Size 10x10x10, Part Number T50 SN010
Manufacturer
In2bones USA, LLC
Affected units
30

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Lot Number: 9G88C0

Distribution

Distributed in 11 states: