Recall Z-2506-2021 ยท LXH Orthopedic Manual Surgical Instrument
In2bones USA, LLC
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.
| Date | Aug 18, 2021 |
| Status | Terminated |
| Reason | Complaints were received of CoLink Bone Graft Harvesters breaking at the outer tube weld site. |
| Root cause | Process change control |
| Action | The recall letter dated 8/17/2021 was issued by the recalling firm via FedEx on 8/18/2021. It explains the description of the issue, associated risks, and requests the letter recipient to distribute the recall notice to all relevant persons within their organization. The consignee is to identify and quarantine the affected product for return to the firm. |
| Quantity | 835 units |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.