Z-0477-2025Class II

JuggerLoc/ToggleLoc 2.9mm Drill Guide, Model number 110027357

Name: Z-0477-2025 JuggerLoc/ToggleLoc 2.9mm Drill Guide, Model number 110027357
Creator: Biomet, Inc.
Published: 2024-10-21
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2024-10-21 / Open, Classified / root cause: manufacturing process

FDA source

Biomet, Inc. began a recall of JuggerLoc/ToggleLoc 2.9mm Drill Guide, Model number 110027357 on 2024-10-21. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0477-2025
Classification: Class II
Status: Open, Classified
Initiated: 2024-10-21
Posted: 2024-11-15
Recalling firm: Zimmer GmbH
Product: JuggerLoc/ToggleLoc 2.9mm Drill Guide, Model number 110027357
Product code: KDD Kit, Surgical Instrument, Disposable
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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Pending
Quantity in commerce: 691 (US); 2,045 (OUS)
Distribution: Worldwide distribution - US Nationwide and the countries of Australia, Brazil, Canada, Singapore, Switzerland.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0477-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0477-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-11-27	2024-11-15

Product code KDD

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)