FDA Medical Device Recalls (openFDA)
Coloplast Manufacturing US, LLC: Rostorelle L, Polypropylene Mesh, Catalog number 501440, Manufacturer Coloplast A/S 3050 Denmark.
- Recall number
- Z-1341-2013
- Recalling firm
- Coloplast Manufacturing US, LLC
- Product
- Rostorelle L, Polypropylene Mesh, Catalog number 501440, Manufacturer Coloplast A/S 3050 Denmark.
- Status
- Terminated
- Initiated
- 2013-04-12
- Posted
- 2013-05-20
- Terminated
- 2014-01-21
- Reason
- 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.
- Root cause
- 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
- 111
- Distribution
- Nationwide Distribution including AL, CA, CO, DC, IL, IN, KY, MD, MA, MO, NH, OH, RI, and VA.
- Lot, serial or model codes
- 3483171
- 510(k) numbers
- ["K122440"]
- PMA numbers
- not on file
- Product code
- OTO
- Firm FEI
- 2125050
- Firm city
- Minneapolis
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28