Recall Z-1823-2017— Zimmer Dental Inc

Name: FDA recall Z-1823-2017
Creator: U.S. Food and Drug Administration
Published: 2017-03-20

Class II · Terminated

Class II FDA medical device recall by Zimmer Dental Inc, initiated 2017-03-20, terminated 2017-11-01. It names one FDA 510(k) clearance: K082639. Product: Tapered SwissPlus Implant System, Model No. SPB10. Reason: It was manufactured with the minor diameter of the internal thread that is below specification..

Recalling firm: Zimmer Dental Inc
Classification: Class II
Status: Terminated
Initiated: 2017-03-20
Terminated: 2017-11-01
Firm location: Carlsbad, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K082639 — ZIMMER DENTAL TAPERED SWISSPLUS IMPLANTSZimmer Dental, Inc.·cleared 2008-12-19

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 SwissPlus Implant System, Model No. SPB10

Reason for recall

It was manufactured with the minor diameter of the internal thread that is below specification.

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