Recall Z-2144-2014— Zimmer, Inc.

Name: FDA recall Z-2144-2014
Creator: U.S. Food and Drug Administration
Published: 2014-07-17

Class II · Terminated

Class II FDA medical device recall by Zimmer, Inc., initiated 2014-07-17, terminated 2015-02-06. It names 2 FDA 510(k) clearances: K013227, K011028. Product: Tapered-Screw Vent Implant, HA, 4.7mmD x 8mmL x 4.5mm, Part No. TSVWH8 Dental implant component.. Reason: Zimmer Dental is recalling the Tapered Screw-Vent Implant because the inner vial state "03.7 x 8mm" instead of "04.7 x 8 mm.".

Recalling firm: Zimmer, Inc.
Classification: Class II
Status: Terminated
Initiated: 2014-07-17
Terminated: 2015-02-06
Firm location: Warsaw, IN, 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

Tapered-Screw Vent Implant, HA, 4.7mmD x 8mmL x 4.5mm, Part No. TSVWH8 Dental implant component.

Reason for recall

Zimmer Dental is recalling the Tapered Screw-Vent Implant because the inner vial state "03.7 x 8mm" instead of "04.7 x 8 mm."

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