Recall Z-0477-2025— Biomet, Inc.

Name: FDA recall Z-0477-2025
Creator: U.S. Food and Drug Administration
Published: 2024-10-21

Class II · Ongoing

Class II FDA medical device recall by Biomet, Inc., initiated 2024-10-21. FDA's recall record names no specific 510(k) clearance for this event. Product: JuggerLoc/ToggleLoc 2.9mm Drill Guide, Model number 110027357. Reason: 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..

Recalling firm: Biomet, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2024-10-21
Firm location: Warsaw, IN, United States

Product description

JuggerLoc/ToggleLoc 2.9mm Drill Guide, Model number 110027357

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.