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
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-2506-2021 |
| Event ID | 88510 |
| Event 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. |
| Product Type | Devices |
| 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. |
| Quantity | 835 units |
| Recall Reason | Complaints were received of CoLink Bone Graft Harvesters breaking at the outer tube weld site. |
| Device Classification | 20210929 |
| Device Code Info | Lot Numbers: 992921, 1018971, 1046581, and 1070081. |
| Center Classification Date | 20210922 |
| Recall Initiation Date | 20210818 |
| Recalling Firm | In2bones USA, LLC |
| Initial Notification | Letter |
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