Recall Z-0331-2020— Zimmer Biomet, Inc.

Name: FDA recall Z-0331-2020
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: K113718. Product: NCB Straight Narrow Plate, various sizes, Item Nos. 0202267008 0202267010 0202267012 0202267014 0202267016 0202267018. 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

K113718 — NCB STRAIGHT NARROW SHAFT PLATESZimmer GmbH·cleared 2012-01-27

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

NCB Straight Narrow Plate, various sizes, Item Nos. 0202267008 0202267010 0202267012 0202267014 0202267016 0202267018

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.