Coloplast, Restorelle DirectFix, Posterior Polypropylene Mesh, Catalogue Number 501460, Rx Only, Manufacturer, Coloplast
FDA device recall Z-1481-2012 · posted 2012-05-02 · Terminated
Recall details
- Recalling firm
- Coloplast Manufacturing US, LLC
- Reason for recall
- Coloplast is conducting a field correction based on the conclusion that two lots of Restorelle DirectFix Posterior mesh were mislabeled. The incorrect size was printed on the patient label. Specifically the patient label depicts the size as 16x11 cm, however, the correct size is actually 14x15 cm. It is important to note that both the product and box labels were correct.
- Action taken
- Coloplast sent a notification letter dated March 2, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The customers were informed their coloplast representative is providing replacement device (s) and new patient labels. For further questions please call 1 (800) 258-3476.
- Root cause
- Error in labeling
- Status
- Terminated
- Product code
- FTL
- Quantity affected
- 134
- Distribution
- USA ( nationwide) including the states of AL, AZ, AR, CA, CO, FL, GA, ID, IL, KY, MD, MS, MO, NY, PA, TN, VA,WA and WI.
- Date initiated
- 2012-03-02
- Date posted
- 2012-05-02
- Date terminated
- 2012-10-11
- Location
- Minneapolis, MN
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| RESTORELLE POLYPROPYLENE MESH; RESTORELLE POLYPROPYLENE MESH (K103568) | Coloplast A/S | 2010-12-22 |
| MODIFICATION TO: MINIMESH POLYPROPYLENE MESH (K053361) | Mpathy Medical Devices, Ltd. | 2006-02-06 |
| MINIMESH POLYPROPYLENE MESH (K041632) | Mpathy Medical Devices, Ltd. | 2004-11-17 |