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Terminated

Virtual XD Refill Light Body Regular Set Wash Material, 2X50 ml, REF #/Product Code 646462, Rx ONLY -- Product Usage: Dental impression material

FDA Recall Z-0718-2017 · Posted None

Recalling FirmIvoclar Vivadent, Inc.
Recall StatusTerminated
Product CodeELW
Date Initiated2016-11-09
Date Terminated2018-06-18
Product QuantityUS: 1867 units, Canada: 465 units

Reason for Recall

The firm received complaints claiming the dental material failed to set up. As the dental material ages, the set time may increase.

Firm Action

Ivoclar Vivadent sent and URGENT - MEDICAL DEVICE RECALL Letters (dated 11/07/2016) and Recall Response Forms to customers via Certified Mail-Return Receipt Requested. The letter identified the affected product, problem and actions to be taken. Customers were advised to return all affected products in stock. For questions contact Ivoclar Vivadent Customer Service at 800-533-6825.

Root Cause

Under Investigation by firm

Distribution Pattern

Worldwide Distribution - US Nationwide and the countries of Canada and Australia

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K083739HYDRORISE AND HYDROSYSTEMZhermack S.P.A. · 2009-03-26

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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