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

Recall Z-2237-2016 — Replace Select Tapered TiU NP 3.5x11.5mm, Article No. 36105 Replace Select Tapered implants are root-form endosseous implants intended to be surgically placed in the bone of the upper and lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore patie

U.S. FDA — Device Enforcement · United States · 2016-06-22 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2237-2016
Date of alert: 2016-06-22
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): 13030677

Reported risk: Incorrect top label on an implant package.

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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