GIBSON Healthcare Membrane 6-9 — Class II medical device recall Z-0909-2020
Terminated recall by Collagen Matrix Inc, reported 2020-02-05, distributed nationwide. The products may have been packaged with an incorrect Instructions for Use.
| Recall number | Z-0909-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Collagen Matrix Inc, Oakland, NJ, United States |
| Recall initiated | 2019-11-05 |
| Classified | 2020-01-29 |
| Reported by FDA | 2020-02-05 |
| Terminated | 2020-08-03 |
| Distributed | Nationwide (US) |
| Quantity | 192 total |
| UPC / GTIN / UDI-DI | 00366975013255 |
| Lot numbers | PDMU19C1 |
Product
GIBSON Healthcare Membrane 6-9, 30mm x 40mm, Reference Number 5303-299 - 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.
Reason for recall
The products may have been packaged with an incorrect Instructions for Use.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0909-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.