Recall Z-0338-2020— Zimmer Biomet, Inc.

Name: FDA recall Z-0338-2020
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: K120772. Product: cable button for NCB¿ Polyaxial Locking Plate, 2.5 mm Hex Drive, Item No. 47223206001. 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

K120772 — NCB PERIPROSTHETIC TROCHANTER PLATES AND SCREWS, NCB CABLE BUTTON FOR NCB OPLYAXIAL LOCKING PLATEZimmer GmbH·cleared 2012-06-12

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

cable button for NCB¿ Polyaxial Locking Plate, 2.5 mm Hex Drive, Item No. 47223206001

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.