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Terminated

Rostorelle L, Polypropylene Mesh, Catalog number 501440, Manufacturer Coloplast A/S 3050 Denmark.

FDA Recall Z-1341-2013 · Posted 2013-05-20

Recalling FirmColoplast Manufacturing US, LLC
Recall StatusTerminated
Product CodeOTO
Date Initiated2013-04-12
Date Terminated2014-01-21
Product Quantity111

Reason for Recall

Coloplast is recalling one lot of Restorelle L prosthesis because it is mislabeled. The incorrect Instructions For Use (IFU) pamphlet is included in the packaging.

Firm Action

Coloplast sent a letter to dated April 12, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. The letter included an attachment with the correct IFU to replace the incorrect IFU. Customers with questions were instructed to call Customer Service at 800-258-3476. For questions regarding this recall call 612-302-4992.

Root Cause

Labeling mix-ups

Distribution Pattern

Nationwide Distribution including AL, CA, CO, DC, IL, IN, KY, MD, MA, MO, NH, OH, RI, and VA.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K122440RESTORELLE LColoplast Corp. · 2012-11-19

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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