PlainRecalls
FDA Devices Moderate Class II Ongoing

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

Reported: November 16, 2022 Initiated: September 30, 2022 #Z-0197-2023

Product Description

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

Details

Units Affected
150 units US; 1116 units OUS
Distribution
FL, GA, IN, LA, MA, ME, VA Foreign: France, Japan, Netherlands, Switzerland, United Kingdom
Location
Waltham, MA

Frequently Asked Questions

What product was recalled?
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. Recalled by Beaver Visitec International, Inc.. Units affected: 150 units US; 1116 units OUS.
Why was this product recalled?
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
Which agency issued this recall?
This recall was issued by the FDA Devices on November 16, 2022. Severity: Moderate. Recall number: Z-0197-2023.