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

Recall Insight

This FDA Devices action (record #Z-1936-2013) was formally reported on August 21, 2013, with the manufacturer initiating the action on July 19, 2013. It is classified under Moderate severity (Class II), with a current status of Terminated. Atrium Medical Corporation is listed as the recalling firm, operating out of Hudson, NH. Federal records indicate 32,834 units units are affected.

The documented reason for this recall is: Additional Instructions for Use and Storage Conditions as Coated mesh can adhere to the inner packaging liner due to exposure to high humidity conditions Distribution data in the federal record shows the product reached: 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 Ire…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 13 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.