Z-0669-2022Class II

RESODURA matrix onlay 10.0 cm x 12.5 cm - indicated as dural substitutes for the repair of dura matter. REF...

Name: Z-0669-2022 RESODURA matrix onlay 10.0 cm x 12.5 cm - indicated as dural substitutes for the repair of dura matter. REF...
Creator: Collagen Matrix, Inc.
Published: 2021-12-13
License: https://open.fda.gov/license/

Collagen Matrix, Inc / initiated 2021-12-13 / Terminated / root cause: manufacturing process

FDA source

Collagen Matrix, Inc. began a recall of RESODURA matrix onlay 10.0 cm x 12.5 cm - indicated as dural substitutes for the repair of dura matter. REF: DUMO10125 on 2021-12-13. FDA classified it as Class II and gives the reason as "Outer packaging (outer pouch) is not sealed compromising sterility and result in potential risk of patient infection, which could lead to revision surgery". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0669-2022
Classification: Class II
Status: Terminated
Initiated: 2021-12-13
Posted: 2022-02-24
Terminated: 2024-09-18
Recalling firm: Collagen Matrix, Inc
Product: RESODURA matrix onlay 10.0 cm x 12.5 cm - indicated as dural substitutes for the repair of dura matter. REF: DUMO10125
Product code: GXQ Dura Substitute
Reason for recall: Outer packaging (outer pouch) is not sealed compromising sterility and result in potential risk of patient infection, which could lead to revision surgery
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: On Monday, December 6, 2021, Collagen Matrix Inc began informing the distributors (initial consignees) to place the lot in question on ship hold. On Monday, December 13, 2021, Collagen Matrix began issuing Urgent Medical Device Recall Notice letter to distributors via email. Letter states reason for recall, health risk and action to take: Check your inventory and that of your sub-distributors if applicable to determine if any of the affected product remains in stock and segregate all affected units from your inventory for return. Complete the Certificate of Acknowledgement form with the appropriate information and return within 5 days of receiving this notice. The completed form can be emailed to [email protected] or returned by mail to: Product Recall Collagen Matrix, Inc. 15 Thornton Road Oakland, NJ 07436 Upon receipt of the completed form, Collagen Matrix will ship replacement product and a prepaid return shipping label will be provided with further instructions for returning product that remains in your possession return the concerned products. If you have any questions after reviewing this notice, please call 201-405-1477, ext. 303 between 8:00am and 5:00pm EST, Monday through Friday. Calls received outside of call center operating hours will receive a prompt to leave a voicemail
Quantity in commerce: 10 units
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.
Product codes and lots: Lot Number 2107292022 Exp. Date: 7/31/2024 UDI: (01)00813954023267(17)240731(10)2107292022 (note: UDI edited 3/7/2022)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0669-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0668-2022	Class II	Terminated	Voluntary: Firm initiated	2022-03-02	2022-02-24
Z-0669-2022	Class II	Terminated	Voluntary: Firm initiated	2022-03-02	2022-02-24

Product code GXQ

K061487Class IIDuramatrix Collagen Dura Substitute Membrane - Onlay and SuturableCollagen Matrix, Inc. / cleared 2006-06-26

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)