Recall Z-1019-2018— Zimmer Biomet, Inc.

Name: FDA recall Z-1019-2018
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: K960658. Product: CPT 12/14 COCR SIZE 2 STD prosthesis, hip, semi-constrained, metal/polymer, porous uncemented. 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

K960658 — COLLARLESS POLISHED TAPER HIP PROSTHESISZimmer, Inc.·cleared 1996-07-16

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

CPT 12/14 COCR SIZE 2 STD prosthesis, hip, semi-constrained, metal/polymer, porous uncemented

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.