FDA Medical Device Recalls (openFDA)
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
- Recall number
- Z-0197-2023
- Recalling firm
- Beaver Visitec International, Inc.
- 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
- Status
- Open, Classified
- Initiated
- 2022-09-30
- Posted
- 2022-11-08
- Terminated
- not on file
- 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 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.
- Quantity
- 150 units US; 1116 units OUS
- Distribution
- FL, GA, IN, LA, MA, ME, VA Foreign: France, Japan, Netherlands, Switzerland, United Kingdom
- Lot, serial or model codes
- UDI# 00886158001249 LOT#'s: 6034831,6039837
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- HTS
- Firm FEI
- 1211998
- Firm city
- Waltham
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28