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Recall Observatory FDA recall evidence

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.

Z-2506-2021

August 18, 2021

Class II

Product summary

Firm
In2bones USA, LLC
Event
Event 88510
Status
Terminated
Classification
Class II
Quantity
835 units
Official record key
device-enforcement:Z-2506-2021

Official wording

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

Code information: Lot Numbers: 992921, 1018971, 1046581, and 1070081.

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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