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JuggerLoc recallZ-0477-2025 · Biomet, Inc. · initiated Oct 21, 2024

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Biomet, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

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.

FDA root cause category: Process control

What the company is doing

Pending

Recall details

Recall number
Z-0477-2025
Status
Open, Classified
Initiated by the company
Oct 21, 2024
Posted by the FDA
Nov 15, 2024
Recalling firm
Biomet, Inc.
Quantity
691 (US); 2,045 (OUS)
Product code
KDD
Distribution
Worldwide distribution - US Nationwide and the countries of Australia, Brazil, Canada, Singapore, Switzerland.

Product description

JuggerLoc/ToggleLoc 2.9mm Drill Guide, Model number 110027357

Code information (models, lots, serial numbers)

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

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Sources and updates

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