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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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
- Hazard
- 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
Related recalls
Same manufacturer · In2bones USA, LLC
See all →- ModerateNeoSpan compression staple kits missing Magnetic Resonance Conditional labeling symbol
FDA (Devices) · 2026-06-17
- HighCoLink Bone Graft Harvester Recalled for Breaking at Weld Site
FDA (Devices) · 2021-09-29
- ModerateIn2Bones Recalls CoLink Lapidus Plates Due to Incorrect Laser Marking
FDA (Devices) · 2018-08-29
- ModerateIn2Bones Recalls CoLink Lapidus Plates Due to Incorrect Laser Marking
FDA (Devices) · 2018-08-29
Same hazard · incorrect component
See all →- ModerateDeRoyal Myocardial Probe Recall Due to Incorrect Needle Length
FDA (Devices) · 2026-09-30
- HighWaldemar Link Recalls Endo-Model Tibial Plateau Replacement Sets
FDA (Devices) · 2026-08-19
- HighTMJ Bilateral Implants with Incorrect Patient-Specific Components Recalled
FDA (Devices) · 2026-07-01
- HighDisposable 5 Lead Cable System May Contain Non-Approved ECG Leads
FDA (Devices) · 2024-08-28
- HighReverse Shoulder Prosthesis Screws May Have Incorrect Size
FDA (Devices) · 2023-10-18
Similar recalls
- HighMedical Device Recall: Orthopedic Compression Screws with Incorrect Dimensions
FDA (Devices) · 2024-03-27
- ModerateNeoSpan compression staple kits missing Magnetic Resonance Conditional labeling symbol
FDA (Devices) · 2026-06-17
- HighI.B.S. 6.5-C Compression Screw Batch Recalled for Dimensional Mix-Up
FDA (Devices) · 2024-03-27
- ModerateSynthes 0.76 mm Drill Bit Recalled for Incorrect Labeling
FDA (Devices) · 2016-12-07
- ModerateOrthoPediatrics Recalls 2.5mm Drill Bits Due to Packaging Labeling Error
FDA (Devices) · 2013-08-21
- HighSurgical Implant Kit Recall: Incorrect Drill Guide Included
FDA (Devices) · 2022-10-26