DuraMatrix-Onlay Collagen Dura Substitute Membrane 4 inches x 5 inches (10.0cm x 12.5cm) REF: CDSLM45
Reported: March 2, 2022 Initiated: December 13, 2021 #Z-0668-2022
Product Description
DuraMatrix-Onlay Collagen Dura Substitute Membrane 4 inches x 5 inches (10.0cm x 12.5cm) REF: CDSLM45
Reason for Recall
Outer packaging (outer pouch) is not sealed compromising sterility and result in potential risk of patient infection, which could lead to revision surgery
Details
- Recalling Firm
- Collagen Matrix, Inc.
- Units Affected
- 68 units
- Distribution
- 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.
- Location
- Allendale, NJ
Frequently Asked Questions
What product was recalled? ▼
DuraMatrix-Onlay Collagen Dura Substitute Membrane 4 inches x 5 inches (10.0cm x 12.5cm) REF: CDSLM45. Recalled by Collagen Matrix, Inc.. Units affected: 68 units.
Why was this product recalled? ▼
Outer packaging (outer pouch) is not sealed compromising sterility and result in potential risk of patient infection, which could lead to revision surgery
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 2, 2022. Severity: Moderate. Recall number: Z-0668-2022.
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