Recall Z-0305-2020— Zimmer Biomet, Inc.

Name: FDA recall Z-0305-2020
Creator: U.S. Food and Drug Administration
Published: 2019-10-10

Class II · Terminated

Class II FDA medical device recall by Zimmer Biomet, Inc., initiated 2019-10-10, terminated 2020-05-19. It names one FDA 510(k) clearance: K150121. Product: ZPLP Fibular Plate, Item Nos. 00234701504 00234701506 00234701508 00234701510 00234701512 00234701516 00234701604 00234701606 00234701608 00234701610 00234701612 00234701614 00234701616 00234701702 00234701704 00234701706 00234701708 00234701710 00234701712 00234701714 00234701716 00234701718 00234701802 00234701804 00234701806 00234701808 00234701810 00234701812 00234701814 00234701816 00234701818 47235701704 47235701706 47235701708 47235701710 47235701712 47235701714 47235701716 47235701804 47235701806 47235701808 47235701810 47235701812 47235701814 47235701816. Reason: Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration)..

Recalling firm: Zimmer Biomet, Inc.
Classification: Class II
Status: Terminated
Initiated: 2019-10-10
Terminated: 2020-05-19
Firm location: Warsaw, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K150121 — Zimmer Periarticular Plating SystemZimmer, Inc.·cleared 2015-02-23

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

ZPLP Fibular Plate, Item Nos. 00234701504 00234701506 00234701508 00234701510 00234701512 00234701516 00234701604 00234701606 00234701608 00234701610 00234701612 00234701614 00234701616 00234701702 00234701704 00234701706 00234701708 00234701710 00234701712 00234701714 00234701716 00234701718 00234701802 00234701804 00234701806 00234701808 00234701810 00234701812 00234701814 00234701816 00234701818 47235701704 47235701706 47235701708 47235701710 47235701712 47235701714 47235701716 47235701804 47235701806 47235701808 47235701810 47235701812 47235701814 47235701816

Reason for recall

Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).

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