CoLink Bone Graft Harvester Recalled for Breaking at Weld Site
In2bones USA is recalling CoLink Bone Graft Harvesters after reports of the instruments breaking at the outer tube weld site. The recall affects 835 units distributed nationwide across 29 states.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a FDA Class II recall of a surgical instrument with a structural defect (breaking at the weld site) that poses risk of harm during surgical procedures. Although no injuries have been reported, this constitutes a risk-of-harm product where injury has not yet been reported, meeting the High severity criterion.
Plain-English summary
In2bones USA, LLC is recalling CoLink Bone Graft Harvesters, 8mm, Sterile, Disposable (REF G05 S1008) because reports indicate that these instruments break at the outer tube weld site. The product is a surgical instrument designed to assist surgeons in manipulating bone during surgical procedures.
The recall affects 835 units identified by lot numbers 992921, 1018971, 1046581, and 1070081. These units were distributed nationwide to medical facilities across 29 U.S. states: Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Louisiana, Maine, Michigan, Minnesota, Missouri, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, Ohio, Oklahoma, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, and Wisconsin. There was no military or government distribution.
Facilities and healthcare providers in receipt of affected units should verify lot numbers and discontinue use of any recalled devices.
The recalled product
- Product
- 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.
- Manufacturer
- In2bones USA, LLC
- Hazard
- structural-defect
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 (4)
- Lot Numbers: 992921
- 1018971
- 1046581
- and 1070081.
Distribution
Distributed nationwide across the United States.
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