# FDA recall Z-0197-2023

> **Beaver Visitec International, Inc.** · Class II · device recall initiated 2022-09-30.

## Product

Beaver Arthro-Lok Pointed Tip Curve L 4mm Blade-an orthopedic blade, which may be used in various types of orthopedic surgery (i.e. foot, ankle, hand, knee, hip or spine surgery).  Catalog#: 376780

## Reason for recall

Incorrect configuration of the blades in the package. The blades curve to the right instead of curving to the left. If used may cause cause unintended tissue damage during the procedure or if noticed prior to use may cause a delay in surgery

## Distribution

FL, GA, IN, LA, MA, ME, VA Foreign: France, Japan, Netherlands, Switzerland, United Kingdom

## Key facts

- **Recall number:** Z-0197-2023
- **Recalling firm:** Beaver Visitec International, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-09-30
- **Report date:** 2022-11-16

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Waltham, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0197-2023

## Citation

> AI Analytics. FDA recall Z-0197-2023. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-0197-2023. Source: US FDA. Licensed CC0.

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