Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-2453-2019 — Natrelle Inspira, Silicone-Filled Breast Implants, Sterile, for the following style numbers: Style TRL: TRL-110TRL-125,TRL-140,TRL-170,TRL-200,TRL-230,TRL-260,TRL-290,TRL-320,TRL-350,TRL-380,TRL-410,TRL-460,TRL-510,TRL-560,TRL-610; Style TRLP: TRLP-125TRLP-145,TRLP-165,TRLP-190,TRLP-205,TRLP-220

U.S. FDA — Device Enforcement · United States · 2019-07-24 · Class I

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2453-2019
Date of alert: 2019-07-24
Country / jurisdiction: United States
Risk level: Class I
Risk type: recall
Brand: Allergan PLC
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 10888628007659

Reported risk: 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.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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