DVR® CROSSLOCKVOLAR RIM PLATE 131814051Recalls & reported problems
Biomet Orthopedics, LLC · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00880304814769), received between Apr 1, 2022 and Apr 1, 2022 — classified as 1 malfunction.
The most frequently reported specific device problem is “Packaging Problem” (1 report).
1 other recall cover devices cleared under the same FDA submission (K132704); they may or may not involve this specific model.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Packaging Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 1, 2022Packaging Problem; Packaging Problem
IT WAS REPORTED THAT UPON INSPECTION IN THE WAREHOUSE, IT WAS FOUND THAT THERE WAS SCRATCH ON THE STERILE PACKAGE. NO ADVERSE EVENT HAS BEEN REPORTED AS A RESULT OF THE MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13976577 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K132704. One submission often covers many models, so check the product and lot details in each record.
- Z-1082-2016 · Jan 29, 2016 · TerminatedCrosslock DVR ePAK -Sterile, Ref 81180050, are complete surgical sets including plates, screws, and instruments for orthopedic fixation The Cross lock DVR ePAK Volar Rim Plates sy
Other APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT, METAL COMPOSITE devices
- LOCK SCREW SQUARE DRIVE 131827120Biomet Orthopedics, LLC · APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT, METAL COMPOSITE1 recall0 reports
- LOCK SCREW SQUARE DRIVE 131827118Biomet Orthopedics, LLC · APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT, METAL COMPOSITE1 recall0 reports
- IJS IJS-E Base Plate AssemblySkeletal Dynamics L.L.C. · APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT, METAL COMPOSITE28 reports
- NA 390.008Synthes GmbH · APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT, METAL COMPOSITE21 reports
- NA 394.85Synthes GmbH · APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT, METAL COMPOSITE8 reports
- NA 390.003Synthes GmbH · APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT, METAL COMPOSITE8 reports
- NA 294.56Synthes GmbH · APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT, METAL COMPOSITE8 reports
- TRUE/LOK MONOLATERAL/BILATERAL FIXATOR 1Orthofix Srl · Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite6 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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