FDA recall Z-0197-2023

Beaver Visitec International, Inc. · Class II · device

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 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

Distribution

FL, GA, IN, LA, MA, ME, VA Foreign: France, Japan, Netherlands, Switzerland, United Kingdom

Key facts

Status: Ongoing
Initiation date: 2022-09-30
Report date: 2022-11-16
Voluntary/Mandated: Voluntary: Firm initiated
Location: Waltham, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0197-2023