FDA recall Z-0477-2025

Biomet, Inc. · Class II · device

Product

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.

Distribution

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

Key facts

Status
Ongoing
Initiation date
2024-10-21
Report date
2024-11-27
Voluntary/Mandated
Voluntary: Firm initiated
Location
Warsaw, IN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0477-2025