DuraMatrix-Onlay Collagen Dura Substitute Membrane 4 inches x 5 inches (10.0cm x 12.5cm) REF: CDSLM45
FDA device recall Z-0668-2022 · posted 2022-02-24 · Terminated
Recall details
- Recalling firm
- Collagen Matrix, Inc.
- 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
- Action taken
- 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 recalls@collagenmatrix.com 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
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- GXQ
- Quantity affected
- 68 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.
- Date initiated
- 2021-12-13
- Date posted
- 2022-02-24
- Date terminated
- 2024-09-18
- Location
- Allendale, NJ
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DURAMATRIX COLLAGEN DURA SUBSTITUTE MEMBRANE - ONLAY AND SUTURABLE (K061487) | Collagen Matrix, Inc. | 2006-06-26 |