Reported Feb 5, 2020 · Terminated
GIBSON Healthcare Membrane 6-9, 20mm x 30mm, Reference Number 5303-235 - Product Usage: Indicated for use in oral…
Collagen Matrix Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Collagen Matrix Inc · 15 Thornton Rd · Oakland, NJ · 07436-3115
Is this the product you have?
GIBSON Healthcare Membrane 6-920mm x 30mmReference
- Number 5303-235 - Product UsageIndicated 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
- Lot codes and dates
- UDI
(01)00366975013255(17)200630Lot Number PDMU18F1
- UDI
- Amount recalled
- 192 total
This recall covers 6 products
The agency filed one notice per product. You are reading one of them; the other 5 are below.
Where it was sold
Why it was recalled
The products may have been packaged with an incorrect Instructions for Use.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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