Collagen Matrix, Inc. recalls DuraMatrix-Onlay Collagen Dura Substitute Membrane 4 inches x 5 inches (10.0cm x 12.5cm) REF: CDSLM45
- Recall date
- December 13, 2021
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-0668-2022
- FDA classification
- Class II
- Brand / firm
- Collagen Matrix, Inc.
- Sold / distributed
- DuraMatrix-Onlay distributed US Nationwide in the states of FL, IN, Puerto Rico, and the countries of Canada, Chile, and Colombia. RESODURA matrix onlay distributed in Germany.
Why it was recalled
Outer packaging (outer pouch) is not sealed compromising sterility and result in potential risk of patient infection, which could lead to revision surgery
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
DuraMatrix-Onlay Collagen Dura Substitute Membrane 4 inches x 5 inches (10.0cm x 12.5cm) REF: CDSLM45
Get recall alerts
Free email alert whenever Collagen Matrix, Inc. has a new recall — straight from official government data. Unsubscribe anytime.
More recalls from: Collagen Matrix, Inc.