Recall Z-0284-2018— Zimmer Dental Inc

Name: FDA recall Z-0284-2018
Creator: U.S. Food and Drug Administration
Published: 2017-11-20

Class II · Terminated

Class II FDA medical device recall by Zimmer Dental Inc, initiated 2017-11-20, terminated 2024-02-28. It names one FDA 510(k) clearance: K101977. Product: Tapered Screw-Vent MTX Model TSVTB11. Reason: Some implant vial caps in the recalled implant lot may inadvertently crack as the result of a manufacturing assembly condition..

Recalling firm: Zimmer Dental Inc
Classification: Class II
Status: Terminated
Initiated: 2017-11-20
Terminated: 2024-02-28
Firm location: Carlsbad, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K101977 — TAPERED SCREW-VENT T IMPLANTZimmer Dental, Inc.·cleared 2010-09-14

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 Model TSVTB11

Reason for recall

Some implant vial caps in the recalled implant lot may inadvertently crack as the result of a manufacturing assembly condition.

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