Recall Z-1468-2018— Zimmer Biomet, Inc.

Name: FDA recall Z-1468-2018
Creator: U.S. Food and Drug Administration
Published: 2018-03-26

Class II · Terminated

Class II FDA medical device recall by Zimmer Biomet, Inc., initiated 2018-03-26, terminated 2020-11-18. It names one FDA 510(k) clearance: K101622. Product: Zimmer Natural Nail System Tear Drop Guide Wire 2.4 mm Diameter, 70 cm length; Item Number: 47-2490-098-01. Reason: Potential failure of sterile packaging seal..

Recalling firm: Zimmer Biomet, Inc.
Classification: Class II
Status: Terminated
Initiated: 2018-03-26
Terminated: 2020-11-18
Firm location: Warsaw, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K101622 — ZIMMER NATURAL NAIL SYSTEM RETROGRADE FEMORAL NAILSZimmer, Inc.·cleared 2010-10-01

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

Zimmer Natural Nail System Tear Drop Guide Wire 2.4 mm Diameter, 70 cm length; Item Number: 47-2490-098-01

Reason for recall

Potential failure of sterile packaging seal.

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