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

Recall Z-0658-2022 — NobelReplace Conical Connection RP 4.3x11.5 mm REF 36707 STERILE R

U.S. FDA — Device Enforcement · United States · 2021-12-17 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0658-2022
Date of alert
2021-12-17
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Nobel Biocare Usa Llc
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
07332747160529
Reported risk: Due to 16 complaints related to drivers not engaging in implants. According to the firm's investigations, the incorrect offset gauge was potentially used during production of the implants. As a result, this could potentially lead to aborted or a delay in surgical procedure.
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.

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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.