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U.S. Department of Health and Human Services

Class 2 Device Recall Rostorelle L, Polypropylene Mesh

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  Class 2 Device Recall Rostorelle L, Polypropylene Mesh see related information
Date Initiated by Firm April 12, 2013
Date Posted May 20, 2013
Recall Status1 Terminated 3 on January 21, 2014
Recall Number Z-1341-2013
Recall Event ID 64943
510(K)Number K122440  
Product Classification Mesh, surgical, synthetic, urogynecologic, for apical vaginal and uterine prolapse, transabdominally - Product Code OTO
Product Rostorelle L, Polypropylene Mesh, Catalog number 501440, Manufacturer Coloplast A/S 3050 Denmark.
Code Information 3483171
Recalling Firm/
Manufacturer		 Coloplast Manufacturing US, LLC
1601 W River Rd
Minneapolis MN 55411-3431
For Additional Information Contact
612-302-4992
Manufacturer 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.
FDA Determined
Cause 2		 Labeling mix-ups
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.
Quantity in Commerce 111
Distribution Nationwide Distribution including AL, CA, CO, DC, IL, IN, KY, MD, MA, MO, NH, OH, RI, and VA.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = OTO and Original Applicant = COLOPLAST CORP.
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