In2bones USA

4 recalls •

🏥 Medical Devices

• Categories: Surgical Instruments, Implants & Prosthetics

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.

Class I - Dangerous

Complaints were received of CoLink Bone Graft Harvesters breaking at the outer tube weld site.

Aug 18, 2021 Surgical Instruments Nationwide View Details →

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

Class I - Dangerous

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.

Nov 14, 2018 Surgical Instruments View Details →

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, joint fusion, osteotomies and reconstruction of the small bones in the hand, wrist, foot and ankle in both pediatric and adult patients.

Class I - Dangerous

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.

Jul 16, 2018 Implants & Prosthetics Nationwide View Details →

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, joint fusion, osteotomies and reconstruction of the small bones in the hand, wrist, foot and ankle in both pediatric and adult patients.

Class I - Dangerous

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.

Jul 16, 2018 Implants & Prosthetics Nationwide View Details →