Recall Z-0319-2020— Zimmer Biomet, Inc.

Name: FDA recall Z-0319-2020
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: K110836. Product: CLS Brevius Stem Kinectiv, hip prosthesis, various sizes. Item Nos. 0100296050 0100296060 0100296070 0100296080 0100296090 0100296100 0100296112 0100296125 0100296137 0100296150 0100296162 0100296175 0100296200. 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

K110836 — CLS BREVIUS STEM WITH KINECTIV TECHNOLOGYZimmer GmbH·cleared 2011-10-07

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

CLS Brevius Stem Kinectiv, hip prosthesis, various sizes. Item Nos. 0100296050 0100296060 0100296070 0100296080 0100296090 0100296100 0100296112 0100296125 0100296137 0100296150 0100296162 0100296175 0100296200

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.