Recall Z-0911-2020— Collagen Matrix Inc
Class II · Terminated
Class II FDA medical device recall by Collagen Matrix Inc, initiated 2019-11-05, terminated 2020-08-03. It names one FDA 510(k) clearance: K100156. Product: GIBSON Healthcare Membrane Extended, 20mm x 30mm, Reference Number 5303-324 - 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: The products may have been packaged with an incorrect Instructions for Use..
- Recalling firm
- Collagen Matrix Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-11-05
- Terminated
- 2020-08-03
- Firm location
- Oakland, NJ, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
GIBSON Healthcare Membrane Extended, 20mm x 30mm, Reference Number 5303-324 - 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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.