Recall Z-1988-2015 ยท MRD Mammary Sizer
Allergan Inc
Natrelle Re-sterilizable Breast Implant Sizer, Size: 410 cc, Style No. MSZFX410. The product is packaged in a thermoformed tray (double sterile barrier) and enclosed in a labeled carton.
| Date | Jul 7, 2015 (initiated Jun 8, 2015) |
| Status | Terminated |
| Reason | Allergan is recalling the NATRELLE 410cc Re-Sterilizable Breast Implant Sizer because the expired product was shipped to the user level. |
| Root cause | Error in labeling |
| Action | A recall letter dated 6/8/15 was sent to all customers who received the NATRELLE 410 cc Re-Sterilizable Breast Implant Sizer. The letter provides the problem identified and the action to be taken. Customers are instructed to contact GENCO Pharmaceutical Services if the recall actions on the recall letter are unclear. For product returns, customers are instructed to contact GENCO at (877) 319-8966, 7am to 5pm CST. Customers with credit/reimbursements are instructed to contact Allergan at (800) 811-4148, 7am to 5pm PST. Customers with medical inquiries are instructed to contact (800) 433-88 |
| Quantity | 9 units |
| Distribution | CA, IN, MO, NJ, VA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K831566 | CUI MAMMARY PROTHESIS SIZER Cox-Uphuff Intl., Aug 12, 1983 |