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