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

Recall Z-1851-2020 — NobelParallel Conical Connection NP, 3.75x10mm (Endosseous Dental Implant); REF 37965; UDI (01)07332747091441(10)12129104(17)240203 - Product Usage: are intended to be used in the upper or lower jaw bone (osseointegration) and used for anchoring or supporting tooth replacements to restore chewing f

U.S. FDA — Device Enforcement · United States · 2019-08-28 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1851-2020
Date of alert: 2019-08-28
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): 12129104

Reported risk: The top label of article no. 37965, lot 12129104 (immediate packaging of endosseous dental implants ) may incorrectly indicate an implant length of 7mm, which is shorter than the actual length of the implant (10mm).

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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