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
Reported: March 8, 2023 Initiated: January 11, 2023 #Z-1183-2023
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
Details
- Recalling Firm
- Covidien, LP
- Units Affected
- 53 units
- Distribution
- 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.
- Location
- North Haven, CT
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Covidien, LP. Units affected: 53 units.
Why was this product recalled? ▼
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
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 8, 2023. Severity: Moderate. Recall number: Z-1183-2023.
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