# FDA recall Z-0160-2022

> **Limacorporate S.p.A** · Class II · device recall initiated 2021-10-01.

## Product

REF 8420.15.010, Bone Screw/Vite - Ti6AI4V, Self Tapping/Autofilettante, Dia=6.5mm, h=20mm, STERILE R, 2100099, UDI: (01)08033390018845

## Reason for recall

There is a potential that the length of bone screws identified on labeling  may not correspond to the actual length of the screw included.

## Distribution

Worldwide distribution - US Nationwide distribution in the states of CA, FL, MO, KS, CO, TX, KS, IL, PA, NY, NC, MI, MA, OK and the countries of Austria, Croatia, Germany, Ireland, Italy, Japan, Korea, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden.

## Key facts

- **Recall number:** Z-0160-2022
- **Recalling firm:** Limacorporate S.p.A
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-10-01
- **Report date:** 2021-10-27
- **Termination date:** 2024-06-27

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** San Daniele Del Friuli, N/A, Italy

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0160-2022

## Citation

> AI Analytics. FDA recall Z-0160-2022. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-0160-2022. Source: US FDA. Licensed CC0.

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