"2.0MM" SYSTEM PLATE 01-9207Recalls & reported problems
Biomet Microfixation, Inc · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00841036017064), received between May 4, 2026 and May 4, 2026 — classified as 1 injury.
The most frequently reported specific device problem is “Fracture” (1 report).
4 other recalls cover devices cleared under the same FDA submission (K121589, K121624, K854886); 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.
Reports received per month
Most reported problems
Device problems
- Fracture1
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.
InjuryMay 4, 2026Fracture
IT WAS REPORTED THE PATIENT EXPERIENCED MANDIBULAR INSTABILITY DUE TO FRACTURE OF THE PLATES THAT FIXED DURING A RIGHT SAGITTAL OSTEOTOMY. THEREFORE, THE PATIENT UNDERWENT A REVISION PROCEDURE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25068879 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K121589, K121624, K854886. One submission often covers many models, so check the product and lot details in each record.
- Z-1220-2017 · Jan 10, 2017 · Terminated1.5mm System, Cranio-maxillofacial Bone Screws 1.5 x 4mm HT SD X-DR Screw, Bone Screw
- Z-0136-2016 · Aug 6, 2015 · TerminatedNeuro Combo Set Case The cases hold surgical instrumentation in place during handling and storage.
- Z-0137-2016 · Aug 6, 2015 · TerminatedThinflap System Case The cases hold surgical instrumentation in place during handling and storage.
- Z-0108-2011 · Aug 31, 2010 · Terminated2.0/1.0 4 hole long plate (titanium plate ).Lot 120150. Product labeling reads: (1. ) REF: 01-9205, Lot 999999, " 2.0MM" SYSTEM PLATE 4 HOLE PLATE, STRAIGHT, LONG. (2.) QTY
Other COVER, BURR HOLE devices
- GUARDIAN™ 6010St. Jude Medical, Inc. · COVER, BURR HOLE151 reports
- GUARDIAN™ 6010St. Jude Medical, Inc. · COVER, BURR HOLE1 death25 reports
- "1.5MM" SYSTEM 95-1505Biomet Microfixation, Inc · COVER, BURR HOLE23 reports
- "1.5MM" SYSTEM 91-6105Biomet Microfixation, Inc · COVER, BURR HOLE20 reports
- CRANIOFIX® ABSORBABLE FF016Aesculap AG · COVER, BURR HOLE8 reports
- "1.5MM" SYSTEM 91-6106Biomet Microfixation, Inc · COVER, BURR HOLE7 reports
- 1.5MM SYSTEM 91-6105X-50Biomet Microfixation, Inc · COVER, BURR HOLE6 reports
- TMS SYSTEM 25-2007Biomet Microfixation, Inc · COVER, BURR HOLE3 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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