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

Recall Z-0282-2018 — Zimmer Dental Instrument Kit System, Tapered Screw-Vent Implant System surgical kit, Complete, Ref TSVKIT. The label shows the product is Manufactured by Zimmer Dental Inc., Carlsbad, CA. Endosseous dental implant accessories are manually powered devices intended to aid in the placement or remov

U.S. FDA — Device Enforcement · United States · 2017-10-11 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0282-2018
Date of alert: 2017-10-11
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Zimmer Dental Inc
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 63581758

Reported risk: The device may contain a manufacturing condition affecting the geometry of the driver's hex feature which prevents it from properly engaging the fixture mount transfer and/or a dental implant.

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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