Recall Z-3206-2017— Zimmer Dental Inc

Name: FDA recall Z-3206-2017
Creator: U.S. Food and Drug Administration
Published: 2017-07-10

Class II · Terminated

Class II FDA medical device recall by Zimmer Dental Inc, initiated 2017-07-10, terminated 2019-08-05. It names 2 FDA 510(k) clearances: K013227, K011028. Product: ABUT GOLD FRICTION-FIT, REF HLA3G; ABUT GOLD FRICTION-FIT, REF HLA4G; COPING GOLD ENG 5.7 MM, REF HLA5G; COPING GOLD NON-ENG. 3.5, REF NEA3G; COPING GOLD NON-ENG. 4.5, REF NEA4G. Reason: Zimmer Biomet is conducting a medical device field correction for various dental products due to several parts being shipped to the customer with only standard IFUs. All the products were missing supplemental IFUs..

Recalling firm: Zimmer Dental Inc
Classification: Class II
Status: Terminated
Initiated: 2017-07-10
Terminated: 2019-08-05
Firm location: Carlsbad, CA, United States

510(k) clearances named in this recall

2 on FDA's record

K013227 — SCREW VENT IMPLANT; TAPERED SCREW VENT IMPLANTSulzer Dental, Inc.·cleared 2001-11-19
K011028 — SCREW-VENT DENTAL IMPLANT SYSTEMSulzer Dental, Inc.·cleared 2001-05-21

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

ABUT GOLD FRICTION-FIT, REF HLA3G; ABUT GOLD FRICTION-FIT, REF HLA4G; COPING GOLD ENG 5.7 MM, REF HLA5G; COPING GOLD NON-ENG. 3.5, REF NEA3G; COPING GOLD NON-ENG. 4.5, REF NEA4G

Reason for recall

Zimmer Biomet is conducting a medical device field correction for various dental products due to several parts being shipped to the customer with only standard IFUs. All the products were missing supplemental IFUs.

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