Z-0197-2023 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- November 16, 2022
- Initiation Date
- September 30, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 150 units US; 1116 units OUS
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
Distribution Pattern
FL, GA, IN, LA, MA, ME, VA Foreign: France, Japan, Netherlands, Switzerland, United Kingdom
Code Information
UDI# 00886158001249 LOT#'s: 6034831,6039837