FDA Device Intelligence
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Mesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon

FDA product code OWW · Class 2 · General, Plastic Surgery

52
Registered devices
3
Adverse events
3
Recalls
10
510(k) clearances

Devices with this code

Rotium — NANOFIBER SOLUTIONS, INC.SpinMedix® Absorbable Fibrous Membrane — Ningbo Guangyuan Zhixin Biological Technology Co., Ltd.VersaCoat Flowable Hydrogel — Alafair Biosciences, Inc.SpinMedix® Absorbable Fibrous Membrane — Ningbo Guangyuan Zhixin Biological Technology Co., Ltd.SpinMedix® Absorbable Fibrous Membrane — Ningbo Guangyuan Zhixin Biological Technology Co., Ltd.SpinMedix® Absorbable Fibrous Membrane — Ningbo Guangyuan Zhixin Biological Technology Co., Ltd.SpinMedix® Absorbable Fibrous Membrane — Ningbo Guangyuan Zhixin Biological Technology Co., Ltd.BioBrace — Conmed CorporationSpinMedix® Absorbable Fibrous Membrane — Ningbo Guangyuan Zhixin Biological Technology Co., Ltd.VersaWrap — Alafair Biosciences, Inc.SpinMedix® Absorbable Fibrous Membrane — Ningbo Guangyuan Zhixin Biological Technology Co., Ltd.X-Repair — SYNTHASOME, INC.X-Repair — SYNTHASOME, INC.SpinMedix® Absorbable Fibrous Membrane — Ningbo Guangyuan Zhixin Biological Technology Co., Ltd.Rotium Bioresorbable Wick — NANOFIBER SOLUTIONS, INC.SpinMedix® Absorbable Fibrous Membrane — Ningbo Guangyuan Zhixin Biological Technology Co., Ltd.BioBrace — Conmed CorporationSpinMedix® Absorbable Fibrous Membrane — Ningbo Guangyuan Zhixin Biological Technology Co., Ltd.VersaWrap Tendon Protector — Alafair Biosciences, Inc.SpinMedix® Absorbable Fibrous Membrane — Ningbo Guangyuan Zhixin Biological Technology Co., Ltd.X-RepairSL — SYNTHASOME, INC.SpinMedix® Absorbable Fibrous Membrane — Ningbo Guangyuan Zhixin Biological Technology Co., Ltd.X-Repair — SYNTHASOME, INC.VersaWrap — Alafair Biosciences, Inc.

Recent recalls

DateFirmReason
2026-02-06International Life SciencesAugmentation devices failed bacterial endotoxin testing.
2026-02-06International Life SciencesAugmentation devices failed bacterial endotoxin testing.
2026-02-06International Life SciencesAugmentation devices failed bacterial endotoxin testing.

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.