Recall Z-2963-2018— Zimmer Dental Inc

Name: FDA recall Z-2963-2018
Creator: U.S. Food and Drug Administration
Published: 2018-05-10

Class II · Terminated

Class II FDA medical device recall by Zimmer Dental Inc, initiated 2018-05-10, terminated 2020-08-19. It names one FDA 510(k) clearance: K111889. Product: Outer Package Label: Tapered Screw-Vent Implant System, 4.1mm X 10mm, 3.5mm, REF:TSVM4B10, Sterile:R, Rx Only; Inner Package Label: Implant, MTX, 3.7mm x 10mm,3.5mm, REF: TSVB10. Zimmer Dental 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. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load.. Reason: Dental implants have incorrect item/lot numbers and size on the inner package labeling. Correct item/lot numbers and size are on the outer package labeling..

Recalling firm: Zimmer Dental Inc
Classification: Class II
Status: Terminated
Initiated: 2018-05-10
Terminated: 2020-08-19
Firm location: Carlsbad, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K111889 — ZIMMER DENTAL TAPERED SCREW-VENT M IMPLANTZimmer Dental, Inc.·cleared 2011-12-06

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

Outer Package Label: Tapered Screw-Vent Implant System, 4.1mm X 10mm, 3.5mm, REF:TSVM4B10, Sterile:R, Rx Only; Inner Package Label: Implant, MTX, 3.7mm x 10mm,3.5mm, REF: TSVB10. Zimmer Dental 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. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load.

Reason for recall

Dental implants have incorrect item/lot numbers and size on the inner package labeling. Correct item/lot numbers and size are on the outer package labeling.

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