Recall Z-0154-2015— Zimmer Dental Inc

Name: FDA recall Z-0154-2015
Creator: U.S. Food and Drug Administration
Published: 2014-10-01

Class II · Terminated

Class II FDA medical device recall by Zimmer Dental Inc, initiated 2014-10-01, terminated 2015-04-28. It names one FDA 510(k) clearance: K072589. Product: Tapered Screw-Vent Implant, MTX, 4.1mmD X 10mmL X 3.5mm Platform Part No. TSV4B10 Tapered Screw-Vent Implant, MTX, 4.1mmD X 11.5mmL X 3.5mm Platform Part No. TSV4B11 The Tapered Screw-Vent Implants are designed for use in the maxilla or mandible for immediate loading or for loading after a conventional healing period. Implants may be used to replace one or more missing teeth. Reason: Zimmer Dental is recalling Tapered Screw-Vent Implants because the incorrect diameter size was printed on the inner vial..

Recalling firm: Zimmer Dental Inc
Classification: Class II
Status: Terminated
Initiated: 2014-10-01
Terminated: 2015-04-28
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, 4.1mmD X 10mmL X 3.5mm Platform Part No. TSV4B10 Tapered Screw-Vent Implant, MTX, 4.1mmD X 11.5mmL X 3.5mm Platform Part No. TSV4B11 The Tapered Screw-Vent Implants are designed for use in the maxilla or mandible for immediate loading or for loading after a conventional healing period. Implants may be used to replace one or more missing teeth

Reason for recall

Zimmer Dental is recalling Tapered Screw-Vent Implants because the incorrect diameter size was printed on the inner vial.

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