Recall Z-2458-2019— Allergan PLC

Name: FDA recall Z-2458-2019
Creator: U.S. Food and Drug Administration
Published: 2019-07-24

Class I · Ongoing

Class I FDA medical device recall by Allergan PLC, initiated 2019-07-24. It names one FDA 510(k) clearance: K862203. Product: McGhan Croissant-Shaped Tissue Expanders, Style 134 Product Usage: intended for temporary subcutaneous implantation and require periodic, incremental inflation with sterile saline for injection until the desired amount of tissue is developed.. Reason: The action was initiated following notification by the U.S. FDA of their recently updated, global safety information concerning the higher incidence of anaplastic large cell lymphoma (BIA-ALCL) in patients who have textured breast implants..

Recalling firm: Allergan PLC
Classification: Class I
Status: Ongoing
Initiated: 2019-07-24
Firm location: Irvine, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K862203 — MCGHAN MAGNA-SITE(TM) TISSUE EXPANDERMcghan Medical Corp.·cleared 1986-07-23

K-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

McGhan Croissant-Shaped Tissue Expanders, Style 134 Product Usage: intended for temporary subcutaneous implantation and require periodic, incremental inflation with sterile saline for injection until the desired amount of tissue is developed.

Reason for recall

The action was initiated following notification by the U.S. FDA of their recently updated, global safety information concerning the higher incidence of anaplastic large cell lymphoma (BIA-ALCL) in patients who have textured breast implants.

Data sourced from openFDA. This site is unofficial and independent of the FDA.