TAPESTRY Biointegrative Implant TS-5040-02Recalls & reported problems

Embody, Inc. · provided with Insertion Sleeve · 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 00810063820060), received between Jun 29, 2026 and Jun 29, 2026 — 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.

Reports received per month

Last 36 months. The most recent month may be incomplete.

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.

InjuryJun 29, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT WAS INITIALLY IMPLANTED WITH AN EMBODY IMPLANT APPROXIMATELY NINE (9) MONTHS AGO AS PART OF A CLINICAL STUDY. SUBSEQUENTLY, IT WAS REPORTED THAT DURING THEIR 6-MONTH FOLLOW UP APPOINTMENT THAT THE PATIENT WAS EXPERIENCING PAIN AND A SUDDEN TEARING SENSATION WHILE PUTTING ON A BATHROBE. AN ULTRASOUND SHOWED EITHER NONHEALING OR PULLING OFF THE TENDON. PATIENT WAS PRESCRIBED PHYSICAL THERAPY AND THERE ARE CURRENTLY NO PLANS FOR SURGICAL INTERVENTION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Muscle/Tendon Damage; Pain
MAUDE report 25652984 ↗

Device details

UDI-DI	`00810063820060`
Brand	TAPESTRY Biointegrative Implant
Model	TS-5040-02
Company	Embody, Inc.
Product code	OWY · Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon
Class	Class 2
FDA submission	K201572, K212306, K252647
Implant	Yes
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	MR Safe
Status	In Commercial Distribution
Record updated	Mar 9, 2026

Device type (GMDN): Extra-gynaecological surgical mesh, biologic-polymer composite

A partially-bioabsorbable, implantable material (e.g., flat sheet) made from both a bioabsorbable animal-derived biologic (e.g., porcine collagen) and a non-bioabsorbable synthetic polymer (e.g., polypropylene) intended for extra-gynaecological, non-dental tissue repair/reinforcement application(s) [e.g., pericardial reinforcement, plastic surgery, abdominal hernia repair]. It may also be intended as a short-term scaffold for tissue regeneration. Disposable devices associated with implantation may be supplied with the mesh.

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

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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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