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In2bones USA, LLC Recall 88510

Description: 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.

In2bones USA, LLC Recall 88510 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-2506-2021
Event ID88510
Event DescriptionCoLink 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.
Product TypeDevices
DistributionUS 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.
Quantity835 units
Recall ReasonComplaints were received of CoLink Bone Graft Harvesters breaking at the outer tube weld site.
Device Classification20210929
Device Code InfoLot Numbers: 992921, 1018971, 1046581, and 1070081.
Center Classification Date20210922
Recall Initiation Date20210818
Recalling FirmIn2bones USA, LLC
Initial Notification Letter
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