Class II — Collagen Matrix Inc
| Recalling firm | COLLAGEN MATRIX, INC. |
|---|---|
| Registered facility | View this company's 3 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | The products may have been packaged with an incorrect Instructions for Use. |
| Product | GIBSON Healthcare Membrane 6-9, 20mm x 30mm, Reference Number 5303-235 - Product Usage: Indicated for use in oral surgical procedures as a resorbable material for use in augmentation around implants placed in immediate extraction sockets, delayed extraction sockets; localized ridge augmentation for later implantation; alveolar ridge reconstruction for prosthetic treatment; filling of bone defects; guided bone regeneration in dehiscence defects and guided tissue regeneration procedures in periodontal defects. |
| Quantity | 192 total |
| Distribution | US Nationwide distribution in the states of AR, AZ, CA, CO, FL, IL, MA, MD, MI, MN, NC, NJ, NY, OK, PA, SC, TX, UT, VA, and WA. |
| Initiated | 2019-11-05 |
| Classified | 2020-01-29 |
| Terminated | 2020-08-03 |
| Recall number | Z-0908-2020 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Collagen Matrix Inc (Z-0908-2020).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/84334/
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