Z-0197-2023 Class II Ongoing
FDA device recall Z-0197-2023 was initiated by Beaver Visitec International, Inc. on Sep 30, 2022 and is designated Class II. 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… The recall status is ongoing. Affected quantity: 150 units US; 1116 units OUS.
Recall Details
- Product Type
- Devices
- Report Date
- Nov 16, 2022
- Initiation Date
- Sep 30, 2022
- 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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0197-2023
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026