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

Recall Z-0401-2021 — COAPTITE Injectable Implant, injectable, sterile, non-pyrogenic implant composed of spherical particles (75-125 microns in diameter of calcium hydroxylapatite (CaHA), suspended in aqueous based gel carrier. Gel carrier is composed of sodium carboxymethylcellulose, sterile water for injection, and g

U.S. FDA — Device Enforcement · United States · 2020-09-30 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0401-2021
Date of alert: 2020-09-30
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Merz North America, Inc.
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 100127846

Reported risk: The Instructions for Use (IFU) updated 03/02/2020 does not match data listed in the post-approval study.

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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