PEANUT PLATING SYSTEM 24616Recalls & reported problems
Biomet Orthopedics, LLC · Class 2 · Implant
Data updated Oct 16, 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 00880304500433), received between Jan 5, 2021 and Jan 5, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Tear, Rip or Hole in Device Packaging” (1 report).
1 other recall cover devices cleared under the same FDA submission (K070823, K093880); 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 16, 2026.
Most reported problems
Device problems
- Tear, Rip or Hole in Device Packaging1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Patient Involvement1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 5, 2021Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
PRODUCT WAS RETURNED WITH STERILITY BARRIER POTENTIALLY COMPROMISED.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement
MAUDE report 11116201 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K070823, K093880. One submission often covers many models, so check the product and lot details in each record.
- Z-1817-2016 · Apr 1, 2016 · TerminatedVarious trauma and sports medicine instruments and implants. Plate, fixation, bone.
Other Screw, fixation, bone devices
- NA 03.043.029Synthes GmbH · Screw, fixation, bone503 reports
- OSTEORAPTOR 72201995Smith & Nephew, Inc. · Screw, fixation, bone253 reports
- Control 360 SK12Treace Medical Concepts, Inc. · Screw, Fixation, Bone195 reports
- HEALIX PEEK ORTHOCORD 222205Medos International Sàrl · Screw, fixation, bone186 reports
- PRECICE® Bone Transport System STP3.5-350Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-400Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-300Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-200Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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