# Class II recall Z-0157-2027: In2bones USA, LLC

**Predicate Speed & CAPA Advisory Opportunity Score:** 68/100

| Field | Value |
|---|---|
| Record | Device recall |
| Recall number | Z-0157-2027 |
| Recalling firm | In2bones USA, LLC |
| Classification | Class II |
| Status | Ongoing |
| Voluntary / mandated | Voluntary: Firm initiated |
| Specialty | Other |
| 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. |
| Quantity | 29 units |
| Distribution | US Nationwide distribution in the states of FL, GA, HI, NC, OH, PA, SD, TX, VA. |
| Recall initiated | 2026-09-09 |
| Reported | 2026-10-21 |
| Firm location | Cordova, TN, United States |

## Why this score
- Class II recall: usually triggers CAPA and quality-system remediation work.
- Recall is still ongoing.
- Posted 14 days ago.

Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0157-2027%22). Last refreshed: 2026-11-03T18:05:14.713Z.
Data from the FDA openFDA API, which may lag official FDA databases. Informational only; not regulatory or legal advice.