—#210737

Product

JuggerLoc/ToggleLoc 2.9mm Drill Guide, Model number 110027357

FDA product code: KDD — Kit, Surgical Instrument, Disposable
Device class: Class 1
Medical specialty: General, Plastic Surgery
Affected lot / code info: UDI-DI 00880304857254 Lots 0002446326 0002446333 0002452241 0002453378 0002467342 0002476076 0002476077 0002476078 0002481506 0002481724 0002486540 0002486541 0002490256 0002493107 0002496066 0002497715 0002497716 0002500871 0002500872 0002504026 0002504027 0002504031 0002504032 0002504033 0002504034 0002504035 0002504036 0002504037 0002504546 0002513868 0002517982 0002517983 0002527929 0002527931 0002528042 0002528043 0002528044 0002528045 0002544040 0002592614 0002592615 0002592616 0002592617 0002592618 0002602484 0002602487 0002602490 0002614121 0002614122 0002614123 0002624306

Why it was recalled

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 (FDA determination)

Process control

Action the firm took

Pending

Recalling firm

Firm: Biomet, Inc.
Address: 56 E Bell Dr, Warsaw, Indiana 46582-6989

Distribution

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

Timeline

Recall initiated: 2024-10-21
Posted by FDA: 2024-11-15
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #210737. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.