TissueMend® 6495-9-001Recalls & reported problems
Tei Biosciences Inc. · TissueMend® Stryker TissueMend 5 cm x 6 cm · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- 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, 1 still open.
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. How this data works · Data updated Oct 13, 2026.
Recalls naming this device
- May 23, 2023Open, Classified
Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
Z-2085-2023 · Root cause: Under Investigation by firm · FDA record ↗
Other Mesh, surgical devices
- MEDPOR TITAN 81032Stryker Leibinger GmbH & Co. KG · Mesh, surgical1 recall1 report
- Peri-Guard PC1016NSynovis Life Technologies, Inc. · Mesh, surgical1 recall1 report
- Supple Peri-Guard SPG0404Synovis Life Technologies, Inc. · Mesh, surgical1 recall0 reports
- SurgiMend® 606-403-001Tei Biosciences Inc. · Mesh, surgical1 recall0 reports
- SurgiMend® 606-300-006Tei Biosciences Inc. · Mesh, surgical1 recall0 reports
- SurgiMend® 606-300-019Tei Biosciences Inc. · Mesh, surgical1 recall0 reports
- SurgiMend® 606-001-009Tei Biosciences Inc. · Mesh, surgical1 recall0 reports
- SurgiMend® 606-004-105Tei 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 13, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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