Beaver Arthro-Lok Pointed Tip Curve L 4mm Blade-an orthopedic blade, which may be used in various types of orthopedic su
Summary
The FDA issued a Class II for Beaver Arthro-Lok Pointed Tip Curve L 4mm Blade-an orthopedic blade, which may b by Beaver Visitec International, Inc.. 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.
Details
Source
Device Recall
External ID
Z-0197-2023
Action Date
2022-11-16
Status
Ongoing
Category
device
Product Description
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
Lot/Code Info: UDI# 00886158001249 LOT#'s: 6034831,6039837
Quantity Affected: 150 units US; 1116 units OUS
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
Distribution
FL, GA, IN, LA, MA, ME, VA Foreign: France, Japan, Netherlands, Switzerland, United Kingdom
Type: Voluntary: Firm initiated
Recall Initiated: 2022-09-30
Company
Waltham, MA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 134 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Beaver Visitec International, Inc. has 182 FDA actions in our database, including 181 recalls and 1 clearance.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Beaver Visitec International, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Beaver Visitec International, Inc. have FDA actions?
Beaver Visitec International, Inc. has 182 FDA actions in our database, including 181 recalls and 1 device clearance.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0197-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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