Recall Z-0197-2023 ยท HTS Knife, Orthopedic
Beaver Visitec International, Inc.
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
| Date | Nov 8, 2022 (initiated Sep 30, 2022) |
| Status | Open, Classified |
| 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 |
| Root cause | Under Investigation by firm |
| Action | Beaver Visitec informed by a written letter notification coupled with an email on 9/30/22. Letter states reason for recall, health risk and action to take: 1. Immediately examine your inventory and quarantine product from these lots that are subject to recall. If you have further distributed this product, please notify your customers by initiating a sub-recall. Consider all potential users of this product in your user supply chain. You are encouraged to use a copy of this recall notification letter when contacting your customers. 2. Complete the enclosed Business Response Form (BRF) and indica |
| Quantity | 150 units US; 1116 units OUS |
| Distribution | FL, GA, IN, LA, MA, ME, VA Foreign: France, Japan, Netherlands, Switzerland, United Kingdom |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.