FDA Device recall Z-0197-2023
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, a…
- FDA Device
- Class II
- ongoing
- Published 2022-11-16
On 2022-11-16 the FDA classified a Class II recall of 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, a… by Beaver Visitec International, citing 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 pro….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0197-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-09-30 |
| Published | 2022-11-16 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Beaver Visitec International |
| Distribution | FL, GA, IN, LA, MA, ME, VA |
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
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
Identifiers
| code_info | UDI# 00886158001249 LOT#'s: 6034831,6039837 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0197-2023%22
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