FDA recall Z-2506-2021

In2bones USA, LLC · Class II · device

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.

Reason for recall

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

Distribution

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.

Key facts

Status
Terminated
Initiation date
2021-08-18
Report date
2021-09-29
Termination date
2023-08-08
Voluntary/Mandated
Voluntary: Firm initiated
Location
Memphis, TN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2506-2021