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Terminated

Zimmer Dental Tapered Screw-Vent Implant, Catalog TSVT6B13, Lot 62284006

FDA Recall Z-2050-2014 · Posted 2014-07-14

Recalling FirmZimmer, Inc.
Recall StatusTerminated
Product CodeDZE
Date Initiated2014-06-25
Date Terminated2014-10-30
Product Quantity129 units

Reason for Recall

Zimmer Dental is conducting a voluntary recall of a single lot of the Tapered Screw-Vent Implant, Catalog Number TSVT6B13, Lot number 62284006, due to a potential crack in the cap of the outer vial.

Firm Action

Recall notification letters sent to customers on 06/25/14. The recall letter, titled "URGENT DEVICE RECALL NOTICE", delivered to customers via a courier, with instructions for returning any unused affected product. The recall letter was accompanied with a response form and provided the following information to customers: product information with codes, reason for recall, risks, responsibilities, MedWatch Reporting and contacting information.

Root Cause

Under Investigation by firm

Distribution Pattern

Nationwide Distribution.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K101880TAPERED SCREW-VENT T IMPLANT, TAPERED SCREW-VENT P IMPLANTZimmer Dental, Inc. · 2010-10-01K101977TAPERED SCREW-VENT T IMPLANTZimmer Dental, Inc. · 2010-09-14

Official Source

View FDA Recall →

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

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