Recall Z-1183-2023— Covidien, LP

Name: FDA recall Z-1183-2023
Creator: U.S. Food and Drug Administration
Published: 2023-01-11

Class II · Ongoing

Class II FDA medical device recall by Covidien, LP, initiated 2023-01-11. It names one FDA 510(k) clearance: K173796. Product: Parietex Composite Mesh Polyester with Absorbable Collagen Film, Horseshoe- Shaped, 9 x 8 cm (3.6" x 3.1"). Intended for the reinforcement of tissues during surgical repair Model Number: PCO2H3. Reason: Collagen film was placed on the opposite side of the mesh may cause delay to treatment/therapy, adhesions, erosion/migration, pain, fistula, hernia (recurrence), and failure of implant.

Recalling firm: Covidien, LP
Classification: Class II
Status: Ongoing
Initiated: 2023-01-11
Firm location: North Haven, CT, United States

510(k) clearances named in this recall

1 on FDA's record

K173796 — Parietex Surgical Mesh (modified into Parietex Hydrophilic 2D, 3D, Anatomical Mesh), Parietex Composite Mesh (PCO and PCO-OS references), Parietex Optimized Composite Mesh (PCO-X, PCO-FX and PCO-OSX references)Sofradim Production·cleared 2018-03-09

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

Parietex Composite Mesh Polyester with Absorbable Collagen Film, Horseshoe- Shaped, 9 x 8 cm (3.6" x 3.1"). Intended for the reinforcement of tissues during surgical repair Model Number: PCO2H3

Reason for recall

Collagen film was placed on the opposite side of the mesh may cause delay to treatment/therapy, adhesions, erosion/migration, pain, fistula, hernia (recurrence), and failure of implant

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