Class II — In2bones USA, LLC
| Recalling firm | In2Bones USA, LLC |
|---|---|
| Registered facility | IN2BONES USA, LLC (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Complaints were received of CoLink Bone Graft Harvesters breaking at the outer tube weld site. |
| 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. |
| 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. |
| Initiated | 2021-08-18 |
| Classified | 2021-09-22 |
| Terminated | 2023-08-08 |
| Recall number | Z-2506-2021 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — In2bones USA, LLC (Z-2506-2021).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/88510/
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