Recall Z-1236-2018— Zimmer Biomet, Inc.

Name: FDA recall Z-1236-2018
Creator: U.S. Food and Drug Administration
Published: 2018-03-12

Class II · Terminated

Class II FDA medical device recall by Zimmer Biomet, Inc., initiated 2018-03-12, terminated 2019-11-18. It names one FDA 510(k) clearance: K091976. Product: Phoenix Nail System, intended for use with an intramedullary nail system for alignment, stabilization and fixation of fractures. 3.5mm Inserter Connector, Short; Model Number: 14-441045; Kit Model Numbers: 14-400082, 14-400082S, 14-440065S, 14-442000-00, 14-442000S, 14-444000-00, 979105, 14-441045-00, and 14-444000S. Reason: Certain lots of the Phoenix Tibia Nail 3.5mm Inserter instruments are being recalled due to reports of fracturing and remaining in the device implant..

Recalling firm: Zimmer Biomet, Inc.
Classification: Class II
Status: Terminated
Initiated: 2018-03-12
Terminated: 2019-11-18
Firm location: Warsaw, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K091976 — BIOMET PHOENIX ANKLE NAIL AND ANKLE ARTHRODESIS NAILBiomet Trauma·cleared 2009-08-17

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

Phoenix Nail System, intended for use with an intramedullary nail system for alignment, stabilization and fixation of fractures. 3.5mm Inserter Connector, Short; Model Number: 14-441045; Kit Model Numbers: 14-400082, 14-400082S, 14-440065S, 14-442000-00, 14-442000S, 14-444000-00, 979105, 14-441045-00, and 14-444000S

Reason for recall

Certain lots of the Phoenix Tibia Nail 3.5mm Inserter instruments are being recalled due to reports of fracturing and remaining in the device implant.

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