MEDPOR TITAN 81032Recalls & reported problems
Stryker Leibinger GmbH & Co. KG · Orbital Floor and Wall MTB Right · Class 2 · Implant
All models of MEDPOR TITAN (5)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613252084334), received between Nov 10, 2025 and Nov 10, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Component Missing” (1 report).
1 FDA recall record name this device's identifier.
2 other recalls cover devices cleared under the same FDA submission (K040364); 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
Recalls naming this device
- Dec 29, 2021Class IITerminated
Inside the packaging of one reported item a non-conforming product was found. Contrary to the design, the barrier layer was manufactured on the inferior side of the implant versus the superior side.
Z-0715-2022 · Root cause: Process control · Recall details · FDA record ↗
Most reported problems
Device problems
- Component Missing1
Patient problems
- Insufficient Information1
- 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.
InjuryNov 10, 2025Component Missing; Component Missing
IT WAS REPORTED BY THE DISTRIBUTOR THAT THE PACKAGING WAS FOUND EMPTY UPON OPENING AND THE NURSE OPENED ANOTHER PACK TO COMPLETE THE CASE.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 23512830 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K040364. One submission often covers many models, so check the product and lot details in each record.
- Z-1093-2015 · Dec 17, 2014 · TerminatedMEDPOR TITAN MAX Orbital Floor and Wall (OFW) MEDPOR-Titanium-Barrier (MTB) Right Product Usage: MEDPOR Implants in block, sheet and pre-formed shapes are intended for non-weight-
- Z-0922-2012 · Dec 16, 2011 · TerminatedMEDPOR TITAN Cranial Temporal with Template - Right, Catalog Number 81038. MEDPOR Biomaterial with embedded Titanium Mesh Implants are intended for non-weight bearing applications
Other Mesh, surgical devices
- Peri-Guard PC1016NSynovis Life Technologies, Inc. · Mesh, surgical1 recall1 report
- SurgiMend® 606-200-020Tei Biosciences Inc. · Mesh, surgical1 recall0 reports
- SurgiMend® 606-005-001Tei Biosciences Inc. · Mesh, surgical1 recall0 reports
- SurgiMend® 606-300-008Tei Biosciences Inc. · Mesh, surgical1 recall0 reports
- SurgiMend® 606-200-016Tei Biosciences Inc. · Mesh, surgical1 recall0 reports
- SurgiMend® 606-300-021Tei Biosciences Inc. · Mesh, surgical1 recall0 reports
- SurgiMend® 606-206-007Tei Biosciences Inc. · Mesh, surgical1 recall0 reports
- SurgiMend® 606-003-001Tei Biosciences Inc. · Mesh, surgical1 recall0 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 · 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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