Recall Z-0669-2022— Collagen Matrix, Inc.

Name: FDA recall Z-0669-2022
Creator: U.S. Food and Drug Administration
Published: 2021-12-13

Class II · Terminated

Class II FDA medical device recall by Collagen Matrix, Inc., initiated 2021-12-13, terminated 2024-09-18. It names one FDA 510(k) clearance: K061487. Product: RESODURA matrix onlay 10.0 cm x 12.5 cm - indicated as dural substitutes for the repair of dura matter. REF: DUMO10125. Reason: Outer packaging (outer pouch) is not sealed compromising sterility and result in potential risk of patient infection, which could lead to revision surgery.

Recalling firm: Collagen Matrix, Inc.
Classification: Class II
Status: Terminated
Initiated: 2021-12-13
Terminated: 2024-09-18
Firm location: Allendale, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K061487 — DURAMATRIX COLLAGEN DURA SUBSTITUTE MEMBRANE - ONLAY AND SUTURABLECollagen Matrix, Inc.·cleared 2006-06-26

K-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

RESODURA matrix onlay 10.0 cm x 12.5 cm - indicated as dural substitutes for the repair of dura matter. REF: DUMO10125

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.