FDA-Device2022-11-16Class II
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
Beaver Visitec International, Inc.
Hazard
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
Sold states
FL, GA, IN, LA, MA, ME, VA Foreign: France, Japan, Netherlands, Switzerland, United Kingdom
Affected count
150 units US; 1116 units OUS
Manufactured in
500 Totten Pond Rd, 10 City Point, Waltham, MA, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0197-2023Don't want to check this manually?
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