JuggerLoc/ToggleLoc 2.9mm Drill Guide, Model number 110027357
FDA device recall Z-0477-2025 · posted 2024-11-15 · Open, Classified
Recall details
- Recalling firm
- Biomet, Inc.
- 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.
- Action taken
- Pending
- Root cause
- Process control
- Status
- Open, Classified
- Product code
- KDD
- Quantity affected
- 691 (US); 2,045 (OUS)
- Distribution
- Worldwide distribution - US Nationwide and the countries of Australia, Brazil, Canada, Singapore, Switzerland.
- Date initiated
- 2024-10-21
- Date posted
- 2024-11-15
- Location
- Warsaw, IN
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