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Terminated

Tapered Screw-Vent Implant, MTX, 4.7mm x 11.5mm, 4.5mm Platform. Catalog Number TSVWB11, Lot 62470008. Class II, 510(k) K13227.

FDA Recall Z-0847-2014 · Posted 2014-01-28

Recalling FirmZimmer Dental Inc
Recall StatusTerminated
Product CodeDZE
Date Initiated2014-01-06
Date Terminated2014-07-07
Product Quantity307

Reason for Recall

Zimmer Dental is conducting a voluntary recall of a single lot of the Tapered Screw-Vent Implant, Catalog TSVWB11, Lot 62470008, because some of the packages of this lot may have the Cap Label state 3.7 x 10mm instead of 4.7 x 11.5mm.

Firm Action

Zimmer Dental initiated the recall on 01/06/2013 by sending out recall notifications via FedEx to domestic customers and via electric mail to international customers. Customers are sent a letter identifying the issue, product description with codes, risk, instructions, and contact information. The letter's instructions include locating the affected product and return unused product to Zimmer Dental and notifying the amount of product that has been consumed.

Root Cause

Labeling Change Control

Distribution Pattern

Worldwide Distribution-USA (nationwide) and the countries of Thailand, Japan, Hong Kong, Morocco, and UAE.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K072589TAPERED SCREW-VENT IMPLANT, 4.1MM, MODELS: TSV4B8, B10, B11, B13 AND B16, TSV4H8, H11, H13 AND H16Zimmer Dental, Inc. · 2007-10-04

Official Source

View FDA Recall →

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

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