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Recall

Class II — Beaver Visitec International, Inc.

Recalling firmBeaver-Visitec International, Inc.
Registered facilityBeaver-Visitec International, Inc (the firm's only registered facility)
ClassificationClass II
StatusOngoing
ReasonIncorrect 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
ProductBeaver 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
Quantity150 units US; 1116 units OUS
DistributionFL, GA, IN, LA, MA, ME, VA Foreign: France, Japan, Netherlands, Switzerland, United Kingdom
Initiated2022-09-30
Classified2022-11-07
Recall numberZ-0197-2023
InitiationVoluntary: 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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