Biomet, Inc.: Device Recall

Recall #Z-0477-2025 · 10/21/2024

Class II: Risk

Recall Details

Recall Number
Z-0477-2025
Classification
Class II
Product Type
Device
Recalling Firm
Biomet, Inc.
Status
Ongoing
Date Initiated
10/21/2024
Location
Warsaw, IN, United States
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
691 (US); 2,045 (OUS)

Reason for Recall

Firm received complaints reporting that guides were warped when pulled out of packaging. This issue may result in extension of surgery to find another product, or may lead to adverse local tissue reaction leading to surgical intervention.

Product Description

JuggerLoc/ToggleLoc 2.9mm Drill Guide, Model number 110027357

Distribution Pattern

Worldwide distribution - US Nationwide and the countries of Australia, Brazil, Canada, Singapore, Switzerland.

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.