Z-2506-2021 Class II Terminated
FDA device recall Z-2506-2021 was initiated by In2bones USA, LLC on August 18, 2021 and is designated Class II. Reason for recall: Complaints were received of CoLink Bone Graft Harvesters breaking at the outer tube weld site. The recall status is terminated (terminated August 8, 2023). Affected quantity: 835 units.
Recall Details
- Product Type
- Devices
- Report Date
- September 29, 2021
- Initiation Date
- August 18, 2021
- Termination Date
- August 8, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 835 units
Product 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.
Reason for Recall
Complaints were received of CoLink Bone Graft Harvesters breaking at the outer tube weld site.
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.
Code Information
Lot Numbers: 992921, 1018971, 1046581, and 1070081.