Beaver Arthro-Lok Pointed Tip Curve L 4mm Blade-an orthopedic blade, which may be used in various types of orthopedic su

FDA device recall Z-0197-2023 · posted 2022-11-08 · Open, Classified

Recall details

Recalling firm

Beaver Visitec International, Inc.

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

Action taken

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.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

HTS

Quantity affected

150 units US; 1116 units OUS

Distribution

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

Date initiated

2022-09-30

Date posted

2022-11-08

Location

Waltham, MA