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.
FDA Recall Z-1988-2015 · Posted 2015-07-07
Recalling FirmAllergan Inc
Recall StatusTerminated
Product CodeMRD
Date Initiated2015-06-08
Date Terminated2015-12-16
Product Quantity9 units
Reason for Recall
Allergan is recalling the NATRELLE 410cc Re-Sterilizable Breast Implant Sizer because the expired product was shipped to the user level.
Firm 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) 433-8871, 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
Distribution Pattern
CA, IN, MO, NJ, VA
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.