JuggerLoc/ToggleLoc 2.9mm Drill Guide Warping in Packaging
Biomet's JuggerLoc/ToggleLoc 2.9mm Drill Guide may warp when removed from packaging, potentially extending surgical time or causing tissue damage requiring intervention.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall of surgical tool that may cause adverse local tissue reaction or extended surgical time during use. No injuries or deaths have been reported, fitting the rubric criterion for risk-of-harm products without reported injury.
Plain-English summary
Biomet, Inc. is recalling the JuggerLoc/ToggleLoc 2.9mm Drill Guide, Model 110027357. Approximately 691 units were distributed in the United States and 2,045 units internationally (Australia, Brazil, Canada, Singapore, and Switzerland).
The company received complaints that the drill guides were warping when removed from packaging.
If a warped guide is used during surgery, it may cause the surgical procedure to extend while surgical staff locate an alternative instrument. Additionally, the guide could cause adverse local tissue reaction, potentially requiring further surgical intervention.
The affected lot numbers are identified in the FDA recall notice. This is a Class II recall.
The recalled product
- Product
- JuggerLoc/ToggleLoc 2.9mm Drill Guide, Model number 110027357
- Manufacturer
- Biomet, Inc.
- Hazard
- warping
- tissue-damage
- surgical-complication
Distribution
Distributed nationwide across the United States.
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