Tritium® Sternal Cable Plate System 86-27-12-S12Recalls & reported problems
Pioneer Surgical Technology, Inc. · Screw 12-pack · Class 2 · Implant
All models of Tritium Sternal Cable Plate System (2)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
1 FDA recall record name this device's identifier.
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.
Recalls naming this device
- Jun 11, 2014Class IITerminated
Lack of Sterility Assurance
Z-2076-2014 · Root cause: Employee error · Recall details · FDA record ↗
Other CERCLAGE, FIXATION devices
- ZipFix 03.501.080Synthes GmbH · CERCLAGE, FIXATION236 reports
- CONTROL 1739-28-000Depuy Orthopaedics, Inc. · CERCLAGE, FIXATION52 reports
- Dall-Miles 6704-0-110Howmedica Osteonics Corp. · CERCLAGE, FIXATION1 recall1 report
- Accord 71340007Smith & Nephew, Inc. · CERCLAGE, FIXATION47 reports
- ZipFix 08.501.001.01SSynthes GmbH · CERCLAGE, FIXATION39 reports
- NA 298.801.01SSynthes GmbH · CERCLAGE, FIXATION33 reports
- ZipFix 08.501.001.05SSynthes GmbH · CERCLAGE, FIXATION29 reports
- NA 298.803SSynthes GmbH · CERCLAGE, FIXATION24 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
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- 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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