Rostorelle L, Polypropylene Mesh, Catalog number 501440, Manufacturer Coloplast A/S 3050 Denmark.
FDA device recall Z-1341-2013 · posted 2013-05-20 · Terminated
Recall details
- Recalling firm
- Coloplast Manufacturing US, LLC
- 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.
- Action taken
- 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
- Status
- Terminated
- Product code
- OTO
- Quantity affected
- 111
- Distribution
- Nationwide Distribution including AL, CA, CO, DC, IL, IN, KY, MD, MA, MO, NH, OH, RI, and VA.
- Date initiated
- 2013-04-12
- Date posted
- 2013-05-20
- Date terminated
- 2014-01-21
- Location
- Minneapolis, MN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| RESTORELLE L (K122440) | Coloplast Corp. | 2012-11-19 |