inforMED
OWYClass IIImplant

Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon

General, Plastic Surgery · 21 CFR 878.3300

For reinforcement of soft tissue where weakness exists in tendon repair.

MDR events158All time
Recalls0All time
Registered firms60Currently listed
510(k) clearances14All time

Recent MDR events

158 adverse event reports on file

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Event type breakdown

Injury124
Malfunction34

Most-reported manufacturers

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Smith & Nephew, Inc.136Rotation Medical, Inc.9Rotation Medical5Embody, Inc4Smith & Nephew Inc.2Arthrocare Corporation1Smith And Nephew Inc., Endoscopy Division1

Recalls

0 recall events for this product code

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No recalls on file for this product code.

Registered firms

60 firms currently registered for this product code

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510(k) clearances

14 clearances for this product code

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