Recall Z-0315-2020— Zimmer Biomet, Inc.

Name: FDA recall Z-0315-2020
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 2 FDA 510(k) clearances: K150121, K142579. Product: PERI DIST VOLAR/DORSAL T/DORSAL DELTA RADIAL, Item Nos. 00234801303 00234801304 00234801306 00234801308 00234801310 00234801312 00234801403 00234801404 00234801406 00234801408 00234801410 00234801412 00234802102 00234802104 00234802106 00234802108 00234802110 00234802112 00234802204 00234802206 00234802208 00234802212 00234802508 00234802510 00234802608. 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

2 on FDA's record

K150121 — Zimmer Periarticular Plating SystemZimmer, Inc.·cleared 2015-02-23
K142579 — Zimmer Periarticular Plating SystemZimmer, Inc.·cleared 2014-10-22

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

PERI DIST VOLAR/DORSAL T/DORSAL DELTA RADIAL, Item Nos. 00234801303 00234801304 00234801306 00234801308 00234801310 00234801312 00234801403 00234801404 00234801406 00234801408 00234801410 00234801412 00234802102 00234802104 00234802106 00234802108 00234802110 00234802112 00234802204 00234802206 00234802208 00234802212 00234802508 00234802510 00234802608

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.