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
Z-0197-2023
Product summary
- Event
- Event 91005
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 150 units US; 1116 units OUS
- Official record key
device-enforcement:Z-0197-2023
Official wording
Reason: 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
Code information: UDI# 00886158001249 LOT#'s: 6034831,6039837
Distribution pattern: FL, GA, IN, LA, MA, ME, VA Foreign: France, Japan, Netherlands, Switzerland, United Kingdom
Derived failure modes
-
Unknown
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