Recall Z-0847-2014— Zimmer Dental Inc

Name: FDA recall Z-0847-2014
Creator: U.S. Food and Drug Administration
Published: 2014-01-06

Class II · Terminated

Class II FDA medical device recall by Zimmer Dental Inc, initiated 2014-01-06, terminated 2014-07-07. It names one FDA 510(k) clearance: K072589. Product: Tapered Screw-Vent Implant, MTX, 4.7mm x 11.5mm, 4.5mm Platform. Catalog Number TSVWB11, Lot 62470008. Class II, 510(k) K13227.. Reason: 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..

Recalling firm: Zimmer Dental Inc
Classification: Class II
Status: Terminated
Initiated: 2014-01-06
Terminated: 2014-07-07
Firm location: Carlsbad, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K072589 — TAPERED SCREW-VENT IMPLANT, 4.1MM, MODELS: TSV4B8, B10, B11, B13 AND B16, TSV4H8, H11, H13 AND H16Zimmer Dental, Inc.·cleared 2007-10-04

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.