Class II — Beaver Visitec International, Inc.
| Recalling firm | Beaver-Visitec International, Inc. |
|---|---|
| Registered facility | Beaver-Visitec International, Inc (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| 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 |
| 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 |
| Quantity | 150 units US; 1116 units OUS |
| Distribution | FL, GA, IN, LA, MA, ME, VA Foreign: France, Japan, Netherlands, Switzerland, United Kingdom |
| Initiated | 2022-09-30 |
| Classified | 2022-11-07 |
| Recall number | Z-0197-2023 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Beaver Visitec International, Inc. (Z-0197-2023).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/91005/
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