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

Recall Z-0367-2022 — MENTOR Saline-Filled Breast Implants are constructed from room temperature vulcanized silicone elastomer, made of polydimethylsiloxane. Surgeons inflate the silicone elastomer shell to the desired size with sterile isotonic saline before implantation. The implants are available with SILTEX Textured

U.S. FDA — Device Enforcement · United States · 2021-09-30 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0367-2022
Date of alert: 2021-09-30
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Mentor Texas, LP.
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 81317001171

Reported risk: Due to a manufacturing issue, Implant may have a potentially weakened area on the base patch portion of the implant which may cause leakage/deflation of the affected device.

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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