FDA Device recall Z-2506-2021
CoLink Bone Graft Harvester, 8mm, Sterile, Disposable, REF G05 S1008 - Product Usage: is a general instrument intended for assisting surgeo…
- FDA Device
- Class II
- terminated
- Published 2021-09-29
On 2021-09-29 the FDA classified a Class II recall of CoLink Bone Graft Harvester, 8mm, Sterile, Disposable, REF G05 S1008 - Product Usage: is a general instrument intended for assisting surgeo… by In2bones Usa, citing complaints were received of CoLink Bone Graft Harvesters breaking at the outer tube weld site.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2506-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-08-18 |
| Published | 2021-09-29 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | In2bones Usa |
| Distribution | US |
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.
Reason
Complaints were received of CoLink Bone Graft Harvesters breaking at the outer tube weld site.
Identifiers
| code_info | Lot Numbers: 992921, 1018971, 1046581, and 1070081. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
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FDA Device · Class II · 2018-08-29 · In2bones Usa - CoLink(TM) Lapidus Plate XP, +2 mm, Left, REF P40 ST265, QTY 1, In2Bones Product Usage: The In2Bones USA LLC, CoLink¿ Plating System is ind…
FDA Device · Class II · 2018-08-29 · In2bones Usa
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2506-2021%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.