Recall Register

Food, drugs, devices › Firms

In2bones USA, LLC

FDA recalling firm · 4 enforcement events · 5 product records · 2018–2026 · TN

In2bones USA, LLC has 4 FDA enforcement events on this register (5 product records) between 2018 and 2026: 4 device; the busiest year was 2018 with 2.

0% of its events are Class I; the most common class is Class II (4). 1 event is listed as ongoing; the recalling firm's address is in TN.

Recall classification reflects the relative degree of health hazard. Event counts depend on a firm's size and product range; they are not a comparison of one firm with another.

Enforcement events

InitiatedProduct (first record)TypeClassRecordsStatus
11 May 2026NeoSpan¿ SuperElastic Compression Staple w/Instruments Catalog Number and Product Name T50 SN010 NeoSpan¿ SuperElastic Compression Staple w/Instruments, Size 10x10x10 UDI-DI Code: 00817906020083 T50 SN012 NeoSpan¿ SuperElastic Compression Staple w/Instruments, Size 12x12x12 UDI-DI Code: 00817906020090 T50 SN020…DeviceClass II1Ongoing
18 Aug 2021CoLink Bone Graft Harvester, 8mm, Sterile, Disposable, REF G05 S1008 - Product Usage: is a general instrument intended for assisting surgeons in the manipulation of bone during surgical procedures.DeviceClass II1Terminated
14 Nov 2018NeoSpan SuperElastic Compression Staple w/Instruments, Size 10x10x10, Part Number T50 SN010DeviceClass II1Terminated
16 Jul 2018CoLink(TM) Lapidus Plate XP, +2 mm, Right, REF P40 ST165, QTY 1, In2Bones Product Usage: The In2Bones USA LLC, CoLink¿ Plating System is indicated for stabilization and fixation of fractures, revision procedures, joint fusion, osteotomies and reconstruction of the small bones in the hand, wrist, foot and ankle in…DeviceClass II2Terminated

By type and class

Device4
Class II4

Class I: 0% of this firm's events; 18% of all events on the register.

Events by year

18
19
20
21
22
23
24
25
26
Enforcement events for In2bones USA, LLC by year initiated.

Questions and answers

How many FDA recalls has In2bones USA, LLC had?

4 enforcement events (5 product records) on this register, 2018–2026: 4 device.

Are any In2bones USA, LLC recalls ongoing?

1 event is listed as ongoing in the current openFDA export.

What class are In2bones USA, LLC recalls?

4 Class II. 0% are Class I against 18% of all events on the register. Class reflects the relative degree of health hazard of the product, not the firm.

Where does this data come from?

openFDA food, drug and device enforcement reports (CC0), export dated 28 Sep 2026.

Provenance

Source: openFDA enforcement reports (CC0), export dated 28 Sep 2026. Firm names are grouped exactly as FDA spells them; the same company can appear under several spellings. Only organisations are shown. See the methodology.