Natrelle Re-sterilizable Breast Implant Sizer, Size: 410 cc, Style No. MSZFX410. The product is packaged in a thermoform
FDA device recall Z-1988-2015 · posted 2015-07-07 · Terminated
Recall details
- Recalling firm
- Allergan Inc
- Reason for recall
- Allergan is recalling the NATRELLE 410cc Re-Sterilizable Breast Implant Sizer because the expired product was shipped to the user level.
- Action taken
- 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) 433-8871, option 2, 8am-5pm, PST. Customers with adverse events/product complaints are instructed to call (800) 624-4261, option 3, 8am-5pm CST. On June 12, 2015, Actavis sent follow up letters to customers to include one additional serial number.
- Root cause
- Error in labeling
- Status
- Terminated
- Product code
- MRD
- Quantity affected
- 9 units
- Distribution
- CA, IN, MO, NJ, VA
- Date initiated
- 2015-06-08
- Date posted
- 2015-07-07
- Date terminated
- 2015-12-16
- Location
- Irvine, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CUI MAMMARY PROTHESIS SIZER (K831566) | Cox-Uphuff Intl. | 1983-08-12 |