Bioinductive Implant with Arthroscopic Delivery System - Medium 4397Recalls & reported problems

Smith & Nephew, Inc. · Class 2 · Implant

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports: 1
Deaths reported: 0
Injuries reported: 1
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00854501006142), received between Nov 15, 2021 and Nov 15, 2021 — classified as 1 injury.

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.

Most reported problems

Device problems

Adverse Event Without Identified Device or Use Problem1

Patient problems

Muscle/Tendon Damage1
Pain1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

InjuryNov 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT AFTER A PARTIAL THICKNESS ROTATOR CUFF TEAR OF THE ARTICULAR SIDE PROCEDURE WITH AN IMPLANT OF REGENETEN, THE PATIENT NEVER FELT ALL THE WAY BETTER AND THE PAIN INCREASED. THE MRI SHOWED EITHER NEW OR UNHEALED PARTIAL TEAR OF ARTICULAR SIDE. PATIENT WAS TREATED WITH A SECOND SURGERY, WHICH REVELED WELL INTEGRATED REGENETEN BUT SIGNIFICANT ARTICULAR SIDED TEAR. THE SURGEON PROCEEDED WITH TAKEDOWN AND REPAIR. IT IS UNKNOWN THE OUTCOME OF THE PATIENT.
Patient problems: Muscle/Tendon Damage; Pain
MAUDE report 12816541 ↗

Device details

UDI-DI	`00854501006142`
Brand	Bioinductive Implant with Arthroscopic Delivery System - Medium
Model	4397
Company	Smith & Nephew, Inc.
Product code	OWY · Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon
Class	Class 2
FDA submission	None listed
Implant	Yes
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Oct 4, 2023

Device type (GMDN): Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial

A bioabsorbable, implantable material (e.g., flat sheet) made from animal-derived collagen intended for extra-gynaecological, non-dental tissue repair/reinforcement application(s) [e.g., pericardial reinforcement, plastic surgery, abdominal hernia repair]; some types may also be intended for use as a short-term scaffold for tissue regeneration. It is constructed of collagen, which might be cross-linked (e.g., with glutaraldehyde); it does not include antimicrobial agents/materials. Disposable devices associated with implantation may be supplied with the mesh.

Other Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon devices

TAPESTRY Biointegrative Implant TS-5040-02
Embody, Inc. · Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon
1 report
TAPESTRY Biointegrative Implant TP-4030-01
Embody, Inc. · Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon
1 report

All Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon devices →

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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