Agency classClass IIOur severity:High FDA (Devices)·Z-2506-2021·Announced 2021-09-29

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.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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
Category: Medical Device — Surgical Instrument
Hazard: structural-defect
Affected units: 835

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.

The notice also names 29 states specifically:

Same manufacturer · In2bones USA, LLC

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Same hazard · structural defect