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RejuvaKnee

Model REJ090 · COLLAGEN MATRIX, INC. · DI 00813954026039

OLC — Scaffold, Partial Medial Meniscal Defects Extending Into The Red/White Zone, Resorbable Bovine Collagen · Class II · 21 CFR 878.3300

UDILibrary device dossier · generated 2026-09-11 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.

Recall history (0)

No recalls linked in the loaded window.

Adverse-event reports — MAUDE (0)

Caveat (required reading): MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line is a reporting baseline (average device in the same product code), not a risk measure.

Monthly adverse-event reports for this device versus the product-code average.
Month	This device (reports)	Product-code average (reports per device)
2026-01	0	3

This device (reports/month)Average device in OLC (reports/device/month)

Regulatory clearances

None linked in the loaded window.

Manufacturer compliance record — COLLAGEN MATRIX, INC.

Warning Letter 2016-09-20 Collagen Matrix, Inc.
Warning Letter 2016-09-20 Collagen Matrix, Inc.
Warning Letter 2015-01-08 Collagen Matrix, Inc.
Warning Letter 2015-01-08 Collagen Matrix, Inc.

VAI 2017-07-18 Collagen Matrix Inc · 3 citations
VAI 2017-07-18 Collagen Matrix Inc · 3 citations
NAI 2017-07-13 Collagen Matrix, Inc. · 0 citations
NAI 2017-07-13 Collagen Matrix, Inc. · 0 citations
OAI 2015-11-25 Collagen Matrix, Inc. · 2 citations
OAI 2015-11-25 Collagen Matrix, Inc. · 2 citations
VAI 2011-12-05 Collagen Matrix, Inc. · 3 citations
VAI 2011-12-05 Collagen Matrix Inc · 3 citations
VAI 2011-12-05 Collagen Matrix, Inc. · 3 citations
VAI 2011-12-05 Collagen Matrix Inc · 3 citations