Z-0197-2023Class II

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

Name: Z-0197-2023 Beaver Arthro-Lok Pointed Tip Curve L 4mm Blade-an orthopedic blade, which may be used in various types of...
Creator: Beaver Visitec International, Inc.
Published: 2022-09-30
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2022-09-30 / Open, Classified / root cause: packaging

FDA source

Beaver Visitec International, Inc. began a recall of 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... on 2022-09-30. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0197-2023
Classification: Class II
Status: Open, Classified
Initiated: 2022-09-30
Posted: 2022-11-08
Recalling firm: Becton Dickinson & Co
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
Product code: HTS Knife, Orthopedic
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
Root cause tag: packaging
FDA 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 [email protected] 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 [email protected]. 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 [email protected] and include in the subject line: Master Case PIR 00371817.
Quantity in commerce: 150 units US; 1116 units OUS
Distribution: FL, GA, IN, LA, MA, ME, VA Foreign: France, Japan, Netherlands, Switzerland, United Kingdom
Product codes and lots: UDI# 00886158001249 LOT#'s: 6034831,6039837

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0197-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0197-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-11-16	2022-11-07

Product code HTS

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)