Recall Z-3252-2018— Zimmer Biomet, Inc.

Name: FDA recall Z-3252-2018
Creator: U.S. Food and Drug Administration
Published: 2018-08-03

Class II · Terminated

Class II FDA medical device recall by Zimmer Biomet, Inc., initiated 2018-08-03, terminated 2020-04-10. It names one FDA 510(k) clearance: K110145. Product: Biomet Sports Medii cine Juggerknot Long Flex Drill Bit with Sleeve Nitinol intended to be used for soft tissue to bone fixation with indications for use in: Shoulder, Foot and Ankle, Knee, Hand and Wrist and Hip repair.Stainless Steel, Sterile Item Number: 110016992. Reason: Expiration date incorrectly listed on the label.

Recalling firm: Zimmer Biomet, Inc.
Classification: Class II
Status: Terminated
Initiated: 2018-08-03
Terminated: 2020-04-10
Firm location: Warsaw, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K110145 — BIOMET SPORTS MEDICINE JUGGERKNOT SOFT ANCHORBiomet, Inc.·cleared 2011-03-04

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

Biomet Sports Medii cine Juggerknot Long Flex Drill Bit with Sleeve Nitinol intended to be used for soft tissue to bone fixation with indications for use in: Shoulder, Foot and Ankle, Knee, Hand and Wrist and Hip repair.Stainless Steel, Sterile Item Number: 110016992

Reason for recall

Expiration date incorrectly listed on the label

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