FDAAugust 18, 2021device
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.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Complaints were received of CoLink Bone Graft Harvesters breaking at the outer tube weld site.
What to do
FDA enforcement status: Terminated
Brands named
in2bones
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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- FDAI.B.S¿ 6.5-C Compression screw - diam 6.5mm lg 75mm,Part Number S65 ST1752024-01-26
- FDAI.B.S¿ 6.5-C Compression screw - diam 6.5mm lg 80mm,Part Number S65 ST1802024-01-26
- FDAIn2Bones Shannon Percutaneous Burr - Product Usage: indicated for forefoot mini-invasive and percutaneous surgery.2021-02-09
- FDANeoSpan SuperElastic Compression Staple w/Instruments, Size 10x10x10, Part Number T50 SN0102018-11-14
- FDACoLink(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, f...2018-07-16
- FDACoLink(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, ...2018-07-16
- FDANon-Locking screws in the following lengths: (a) NEO(R) 0.27 - 10 mm, REF W27 ST010 (b) NEO(R) 0.27 - 12 mm, REF W27 ST012 (c) DRP 0.27 - 12 mm, REF W27 ST012 (d) NEO(R) 0.27 - 14 mm, REF W27 ST014 (e) NEO(R) 0.27 - 16 mm, REF W27 ST016 (f) NEO(R) 0.27 - 18 mm, REF W27 ST018 (f) DRP 0.27 - 18 mm,...2017-07-13
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