Recall Z-1021-2018— Zimmer Biomet, Inc.

Name: FDA recall Z-1021-2018
Creator: U.S. Food and Drug Administration
Published: 2017-11-29

Class II · Terminated

Class II FDA medical device recall by Zimmer Biomet, Inc., initiated 2017-11-29, terminated 2020-04-02. It names one FDA 510(k) clearance: K030079. Product: VERSYS 10 INCH BEADED FC REV 15.0X250MM BWD LT & RT VERSYS BEADED FULLCOAT REVISION HIP PROSTHESIS. Reason: The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag..

Recalling firm: Zimmer Biomet, Inc.
Classification: Class II
Status: Terminated
Initiated: 2017-11-29
Terminated: 2020-04-02
Firm location: Warsaw, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K030079 — VERSYS BEADED FULLCOAT BOWED REVISION HIP PROSTHESISZimmer, Inc.·cleared 2003-02-05

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

VERSYS 10 INCH BEADED FC REV 15.0X250MM BWD LT & RT VERSYS BEADED FULLCOAT REVISION HIP PROSTHESIS

Reason for recall

The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag.

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