Recall Z-1190-2018— Zimmer Dental Inc

Name: FDA recall Z-1190-2018
Creator: U.S. Food and Drug Administration
Published: 2017-11-29

Class II · Terminated

Class II FDA medical device recall by Zimmer Dental Inc, initiated 2017-11-29, terminated 2019-02-08. It names one FDA 510(k) clearance: K072589. Product: Tapered Screw-Vent MTX, Dental Implant, sterile. Model TSV4B10.. Reason: Two lots of the Tapered Screw-Vent Implants, with different outer thread diameters, were inadvertently commingled during the manufacturing process and may be mislabeled..

Recalling firm: Zimmer Dental Inc
Classification: Class II
Status: Terminated
Initiated: 2017-11-29
Terminated: 2019-02-08
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 MTX, Dental Implant, sterile. Model TSV4B10.

Reason for recall

Two lots of the Tapered Screw-Vent Implants, with different outer thread diameters, were inadvertently commingled during the manufacturing process and may be mislabeled.

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