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Recall Observatory FDA recall evidence

Device 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

Z-1183-2023

January 11, 2023

Class II

Product summary

Firm
Covidien, LP
Event
Event 91567
Status
Ongoing
Classification
Class II
Quantity
53 units
Official record key
device-enforcement:Z-1183-2023

Official wording

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

Code information: GTIN: A8845211784602 Lot Number: PVE0194M

Distribution pattern: US Distribution to states of: CA, GA, NY and OUS Foreign distribution to countries of: Armenia, Belgium, France, Germany, Israel, Japan, Luxembourg, Romania, Spain, Switzerland and United Kingdom.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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