—#196483

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

FDA product code: HTS — Knife, Orthopedic
Device class: Class 1
Medical specialty: Orthopedic
Affected lot / code info: UDI# 00886158001249 LOT#'s: 6034831,6039837

Why it was recalled

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 (FDA determination)

Under Investigation by firm

Action the firm took

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 indicate whether or not you have affected product to return. Please return the business response form to beavervisitec2765@sedgwick.com even if you no longer have product on hand. 3. Please enter the following information on the enclosed BRF: company name, lot number(s) and quantity(ies) of device(s) that are being returned. 4. If you have any questions regarding this Field Action, please contact BVI Sedgwick at 866-382-8606 or beavervisitec2765@sedgwick.com. If you have affected product, please return product with copy of BRF to: Return your product to SEDGWICK using the enclosed UPS pre-paid return label: Attn: Event 2765 Sedgwick 2670 Executive Drive, Suite A Indianapolis, IN 46241 A credit will be provided to consignees who have replied with confirmation of receiving affected product. Please direct any questions regarding credit to our customer service department by email ClaimsUS@bvimedical.com and include in the subject line: Master Case PIR 00371817.

Recalling firm

Firm: Beaver Visitec International, Inc.
Address: 500 Totten Pond Rd, 10, City Point Waltham, Massachusetts 02451-1916

Distribution

Distribution pattern: FL, GA, IN, LA, MA, ME, VA Foreign: France, Japan, Netherlands, Switzerland, United Kingdom

Timeline

Recall initiated: 2022-09-30
Posted by FDA: 2022-11-08
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #196483. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.