CoLink Bone Graft Harvester recalled over E. coli risk

Recall date

August 18, 2021

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

In2bones USA, LLC recalls CoLink Bone Graft Harvester, 8mm, Sterile, Disposable, REF G05 S1008 - Product Usage: is a general instrument intended…

Recall number

Z-2506-2021

FDA classification

Class II

Brand / firm

In2bones USA, LLC

Sold / distributed

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.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.