Oakland, NJ, United States
Collagen Matrix Inc recalls
6 recalls recorded since 2018, most recently on 3 August 2022. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls6
Ongoing (FDA)1
Terminated or completed5
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 3 August 2022
- Reason
- The packaging may not be sealed, which could compromise sterility.
- Distribution
- US distribution to distributors in IL, IN, MI, NC, OH, and TX
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1777-2022
- Collagen Dental Wound Dressing - Bovine Dermis Tap, 25mm x 75mm Product was distributed under the following brand names: 1) Cytoplast RTMTAPE, 25mm x 75mm 2) GIBSON Healthcare, 25mm x 75mm 3) MaxxTape, 2.5cm
Terminated Class II Medical devices
- Recall started
- 13 December 2021
- Terminated
- 18 September 2024
- Reason
- Outer packaging (outer pouch) is not sealed compromising sterility and result in potential risk of patient infection, which could lead to revision surgery
- 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.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0668-2022, Z-0669-2022
- DuraMatrix-Onlay Collagen Dura Substitute Membrane 4 inches x 5 inches (10.0cm x 12.5cm) REF: CDSLM45
- RESODURA matrix onlay 10.0 cm x 12.5 cm - indicated as dural substitutes for the repair of dura matter. REF: DUMO10125
Terminated Class II Medical devices
- Recall started
- 5 November 2019
- Terminated
- 3 August 2020
- Reason
- The products may have been packaged with an incorrect Instructions for Use.
- 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
- Voluntary: Firm initiated
- Recall numbers
- Z-0911-2020, Z-0910-2020, Z-0907-2020, Z-0909-2020, Z-0908-2020, Z-0912-2020
- 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 immedi
- GIBSON Healthcare Membrane Extended, 15mm x 20mm, Reference Number 5303-306 - - Product Usage: Indicated for use in oral surgical procedures as a resorbable material for use in augmentation around implants placed in imme
- GIBSON Healthcare Membrane 6-9, 15mm x 20mm, Reference Number 5303-226 - Product Usage: Indicated for use in oral surgical procedures as a resorbable material for use in augmentation around implants placed in immediate e
- 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 e
- 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 e
- GIBSON Healthcare Membrane Extended, 30mm x 40mm, Reference Number 5303-342 - Product Usage: Indicated for use in oral surgical procedures as a resorbable material for use in augmentation around implants placed in immedi
Terminated Class II Medical devices
- Recall started
- 19 March 2019
- Terminated
- 12 May 2020
- Reason
- Product was packaged in the wrong box; may have been placed inside a Neomem FLEXPLUS box instead of a Neomem box
- Distribution
- Worldwide distribution - US nationwide in the states of CA, FL and countries of Canada, Israel.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1389-2019
- Neomem Resorbable Collagen Membrane, 15 mm x 20 mm Reference Number (model): N1520 - Product Usage: Neomem is a bioresorbable, implantable collagen material that is intended for use in dental surgery procedures as a mat
Terminated Class III Medical devices
- Recall started
- 30 October 2018
- Terminated
- 12 May 2020
- Reason
- There is a possibility that the product labeled as 4.0cc volume may only contain 2.0cc volume and is therefore mislabeled.
- Distribution
- FL, TX
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0752-2019
- Porcine Anorganic Bone Mineral 4.0cc
Terminated Class III Medical devices
- Recall started
- 16 August 2018
- Terminated
- 23 June 2020
- Reason
- There is a possibility that the product was packaged in the wrong box. Specifically, the product may have been placed inside a BioMend box instead of a BioMend Extend box. The only difference between the two boxes is the product trade name. The label placed on the box and on the product packaged inside the box is correct. The Instructions for Use inside the box are correct.
- Distribution
- Distributed to one distributor located in Florida.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0414-2019
- BioMend Extend, REF# 0142Z, Synthetic bone grafting material.
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.