—#119923

Product

C-QUR Mesh (All Sizes, shapes). Intended for use in soft tissue deficiencies.

FDA product code: FTL — Mesh, Surgical, Polymeric
Device class: Class 2
Medical specialty: General, Plastic Surgery
510(k) numbers: K050311
Affected lot / code info: Product lines with lot number 10405513 and higher

Why it was recalled

Additional Instructions for Use and Storage Conditions as Coated mesh can adhere to the inner packaging liner due to exposure to high humidity conditions

Root cause (FDA determination)

Package design/selection

Action the firm took

Atrium Medical issued Recall Letter via UPS and e-mail on 7/19/13 to the accounts and field representatives. The notification identifies the problem, product, and risk factors. If the Product is exposed to excessive humidity for an extended period of time, then the increased humidity occurring inside the pouch can potentially cause the coating on the mesh to strongly adhere to the inner handling sleeve. A reply for is requested to be completed to acknowledge receipt to the notification. Additional language to the instructions for use (IFU) to include: Prolonged exposure to high humidity may result in increased rate of adherence of the C-QUR mesh to its handling sleeve. Store in a Controlled Room Temperature (25 C / 77 F ) or less. Brief exposure to up to 40 C (104 F ) is acceptable. Questions please contact Atrium Medical Customer Service at 1- 800- 528-7486 Monday through Friday 9:00 am to 5:00 pm EDT.

Recalling firm

Firm: Atrium Medical Corporation
Address: 5 Wentworth Dr, Hudson, New Hampshire 03051-4929

Distribution

Distribution pattern: USA (nationwide) including Puerto Rico and the countries of Australia Austria Bahrain Brazil Canada Chile Colombia Dominican Republic Ecuador El Salvador France Germany Great Britain Greece Honduras Hong Kong India Ireland Israel Italy Japan Jordan Korea Malaysia Mexico Netherlands New Zealand Nicaragua Norway Panama Peru Portugal Romania Saudi Arabia Singapore South Africa Spain Sri Lanka Switzerland Taiwan Thailand Turkey and Venezuela.

Timeline

Recall initiated: 2013-07-19
Posted by FDA: 2013-08-09
Terminated: 2016-03-18
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #119923. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.