Recall Z-1190-2016— Zimmer Spine, Inc.

Name: FDA recall Z-1190-2016
Creator: U.S. Food and Drug Administration
Published: 2016-02-12

Class II · Terminated

Class II FDA medical device recall by Zimmer Spine, Inc., initiated 2016-02-12, terminated 2016-08-11. It names 4 FDA 510(k) clearances: K123552, K122592, K113270 and 1 more. Product: Instinct¿ Java¿ System (IFU reference: 046WAN0000T) . Stabilizes one or more vertebral segments from the thoracic spine to the sacrum during the development of bone tissue.. Reason: Zimmer Biomet is initiating a Medical Device Correction Notice to provide updated cleaning and disinfecting instructions for use of the Instinct¿ Java¿ System (IFU reference: 046WAN0000T) and Universal Clamp¿ System (IFU reference: SNA027-N-90001)..

Recalling firm: Zimmer Spine, Inc.
Classification: Class II
Status: Terminated
Initiated: 2016-02-12
Terminated: 2016-08-11
Firm location: Minneapolis, MN, United States

510(k) clearances named in this recall

4 on FDA's record

K123552 — INSTINCT JAVA SYSTEMZimmer Spine·cleared 2013-04-19
K122592 — INSTINCT JAVA SYSTEMZimmer Spine·cleared 2013-01-04
K113270 — INSTINCT JAVA SYSTEMZimmer Spine·cleared 2011-12-16
K111301 — INSTINCT JAVA SYSTEMZimmer Spine·cleared 2011-08-26

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

Instinct¿ Java¿ System (IFU reference: 046WAN0000T) . Stabilizes one or more vertebral segments from the thoracic spine to the sacrum during the development of bone tissue.

Reason for recall

Zimmer Biomet is initiating a Medical Device Correction Notice to provide updated cleaning and disinfecting instructions for use of the Instinct¿ Java¿ System (IFU reference: 046WAN0000T) and Universal Clamp¿ System (IFU reference: SNA027-N-90001).

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