FDA Device recall Z-0157-2027
REF: P65 ST862 CoLag SCREW, FT, 6.7X62.5 mm
- FDA Device
- Class II
- ongoing
- Published 2026-10-21
On 2026-10-21 the FDA classified a Class II recall of REF: P65 ST862 CoLag SCREW, FT, 6.7X62.5 mm by In2bones Usa, citing due to labeling error, bone screws specified as fully threaded, are actually partially threaded screws.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0157-2027 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-09-09 |
| Published | 2026-10-21 |
| Last updated | 2026-10-27 05:30 UTC |
| Company | In2bones Usa |
| Distribution | US |
Product
REF: P65 ST862 CoLag SCREW, FT, 6.7X62.5 mm
Reason
Due to labeling error, bone screws specified as fully threaded, are actually partially threaded screws.
Identifiers
| code_info | UDI: 00817906023992/Lot: GM008380; GM007868 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-10-27 05:30 UTC. Current status: ongoing.
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FDA Device · Class II · 2019-01-02 · In2bones Usa - CoLink(TM) Lapidus Plate XP, +2 mm, Right, REF P40 ST165, QTY 1, In2Bones Product Usage: The In2Bones USA LLC, CoLink¿ Plating System is in…
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-0157-2027%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.