Recall Z-1081-2019— Zimmer Biomet, Inc.

Name: FDA recall Z-1081-2019
Creator: U.S. Food and Drug Administration
Published: 2019-02-28

Class II · Terminated

Class II FDA medical device recall by Zimmer Biomet, Inc., initiated 2019-02-28, terminated 2020-04-23. It names one FDA 510(k) clearance: K033280. Product: Biomet Small Diameter Cement Plug Inserter-Sterile, single-use accessory instrumentation to be used during surgical procedures utilizing the Small Diameter Cement Plug implant devices Item Number: 414989. Reason: Lack of an adequate sterilization validation.

Recalling firm: Zimmer Biomet, Inc.
Classification: Class II
Status: Terminated
Initiated: 2019-02-28
Terminated: 2020-04-23
Firm location: Warsaw, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K033280 — DISCOVERY ELBOW-MOSAIC DISTAL HUMERAL REPLACEMENT SYSTEMBiomet, Inc.·cleared 2003-12-19

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 Small Diameter Cement Plug Inserter-Sterile, single-use accessory instrumentation to be used during surgical procedures utilizing the Small Diameter Cement Plug implant devices Item Number: 414989

Reason for recall

Lack of an adequate sterilization validation

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