Recall Z-0477-2025 ยท KDD Kit, Surgical Instrument, Disposable
Biomet, Inc.
JuggerLoc/ToggleLoc 2.9mm Drill Guide, Model number 110027357
| Date | Nov 15, 2024 (initiated Oct 21, 2024) |
| Status | Open, Classified |
| 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. |
| Root cause | Process control |
| Action | Pending |
| Quantity | 691 (US); 2,045 (OUS) |
| Distribution | Worldwide distribution - US Nationwide and the countries of Australia, Brazil, Canada, Singapore, Switzerland. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.