Recall Z-0197-2023— Beaver Visitec International, Inc.
Class II · Ongoing
Class II FDA medical device recall by Beaver Visitec International, Inc., initiated 2022-09-30. FDA's recall record names no specific 510(k) clearance for this event. 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: 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.
- Recalling firm
- Beaver Visitec International, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2022-09-30
- Firm location
- Waltham, MA, United States
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.