Recall Z-1988-2015— Allergan Inc
Class II · Terminated
Class II FDA medical device recall by Allergan Inc, initiated 2015-06-08, terminated 2015-12-16. It names one FDA 510(k) clearance: K831566. Product: 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.. Reason: Allergan is recalling the NATRELLE 410cc Re-Sterilizable Breast Implant Sizer because the expired product was shipped to the user level..
- Recalling firm
- Allergan Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-06-08
- Terminated
- 2015-12-16
- Firm location
- Irvine, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Reason for recall
Allergan is recalling the NATRELLE 410cc Re-Sterilizable Breast Implant Sizer because the expired product was shipped to the user level.
Data sourced from openFDA. This site is unofficial and independent of the FDA.