Memphis, TN, United States
In2bones USA, LLC recalls
5 recalls recorded since 2018, most recently on 9 September 2026. 2 are listed as ongoing. Status and classification are as published by the FDA.
Recalls5
Ongoing (FDA)2
Terminated or completed3
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 9 September 2026
- Reason
- Due to labeling error, bone screws specified as fully threaded, are actually partially threaded screws.
- Distribution
- US Nationwide distribution in the states of FL, GA, HI, NC, OH, PA, SD, TX, VA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0157-2027
- REF: P65 ST862 CoLag SCREW, FT, 6.7X62.5 mm
Ongoing Class II Medical devices
- Recall started
- 11 May 2026
- Reason
- Due to the Magnetic Resonance Conditional Symbol missing on the carton, inner tray, and patient label.
- Distribution
- U.S.: AL, AZ, CA, CO, FL, GA, HI, ID, IL, IN, LA, MD, MO, NC, NJ, NV, NY, OH, OK, PA, TN, TX, UT, VA, and WI O.U.S.: Belgium, Canada, Colombia, France, Ireland, Netherlands, Spain, United Kingdom,
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2355-2026
- NeoSpan¿ 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¿
Terminated Class II Medical devices
- Recall started
- 18 August 2021
- Terminated
- 8 August 2023
- Reason
- Complaints were received of CoLink Bone Graft Harvesters breaking at the outer tube weld site.
- Distribution
- US Nationwide distribution in the states of AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, LA, ME, MI, MN, MO, NC, NE, NJ, NM, NV, OH, OK, PA, SC, TN, TX, VA, and WI. There was no military/government distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2506-2021
- CoLink 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.
Terminated Class II Medical devices
- Recall started
- 14 November 2018
- Terminated
- 8 May 2019
- Reason
- 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.
- Distribution
- TX, VA, PA, MO, NJ, FL, TN, NC, OH, WI, LA
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0670-2019
- NeoSpan SuperElastic Compression Staple w/Instruments, Size 10x10x10, Part Number T50 SN010
Terminated Class II Medical devices
- Recall started
- 16 July 2018
- Terminated
- 22 February 2019
- Reason
- CoLink(TM) Lapidus Plate +2mm Right and Left, were laser marked incorrectly. In these lots, right plates were laser marked as left plates and the left plates were laser marked as right plates.
- Distribution
- Worldwide Distribution - US Nationwide and the countries of France
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2879-2018, Z-2880-2018
- CoLink(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, jo
- CoLink(TM) Lapidus Plate XP, +2 mm, Left, REF P40 ST265, QTY 1, In2Bones Product Usage: The In2Bones USA LLC, CoLink¿ Plating System is indicated for stabilization and fixation of fractures, revision procedures, joi
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.