NA 04.315.203Recalls & reported problems
Synthes GmbH · 1.0MM MESH FOOT C-TYPE FOR CMF DISTRACTOR · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10887587015750), received between Dec 4, 2025 and Dec 4, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Mechanical Jam” (2 reports).
2 other recalls cover devices cleared under the same FDA submission (K060138, K162594); 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
- Mechanical Jam2
Patient problems
- Insufficient Information2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 4, 2025Mechanical Jam; Mechanical Jam
IT WAS REPORTED THAT ON AN UNKNOWN DATE DURING MANDIBULAR DISTRACTION WHILE REVIEWING SCAN OF PATIENT, THE SURGEON REALIZED SCREWS IN RAMUS BILATERALLY PULLED OUT OF THE DISTRACTORS AT SOME POINT AND MINIMAL DISTRACTION HAD OCCURRED.
Patient problems: Insufficient Information
MAUDE report 23720645 ↗MalfunctionDec 4, 2025Mechanical Jam; Mechanical Jam
IT WAS REPORTED THAT ON AN UNKNOWN DATE DURING MANDIBULAR DISTRACTION WHILE REVIEWING SCAN OF PATIENT, THE SURGEON REALIZED SCREWS IN RAMUS BILATERALLY PULLED OUT OF THE DISTRACTORS AT SOME POINT AND MINIMAL DISTRACTION HAD OCCURRED.
Patient problems: Insufficient Information
MAUDE report 23720410 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K060138, K162594. One submission often covers many models, so check the product and lot details in each record.
- Z-2148-2014 · Apr 16, 2014 · TerminatedDePuy Synthes Craniomaxillofacial Distraction System (AB Distractor Bodies and BC Distractor Bodies)
- Z-1726-2013 · Jun 12, 2013 · TerminatedSynthes CMF Distraction System The product is intended for use as a bone stabilizer and lengthening (and/or transport) device for correction of congenital deficiencies or post-tra
Other EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR devices
- DISTRACTION, INTERNAL 51-405-42-09KLS-Martin L.P. · EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR20 reports
- LEVEL ONE CMF 50-760-26-09KLS-Martin L.P. · EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR18 reports
- DISTRACTION, INTERNAL 51-563-30-09KLS-Martin L.P. · EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR13 reports
- LEVEL ONE CMF 50-797-26-09KLS-Martin L.P. · EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR13 reports
- LEVEL ONE CMF 50-777-26-09KLS-Martin L.P. · EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR11 reports
- DISTRACTION, INTERNAL 51-526-30-09KLS-Martin L.P. · EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR10 reports
- NA 04.315.125Synthes GmbH · EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR10 reports
- DISTRACTION, INTERNAL 51-401-91-09KLS-Martin L.P. · EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR10 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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