Recall Z-1538-2018— Zimmer Biomet, Inc.

Name: FDA recall Z-1538-2018
Creator: U.S. Food and Drug Administration
Published: 2018-04-02

Class II · Terminated

Class II FDA medical device recall by Zimmer Biomet, Inc., initiated 2018-04-02, terminated 2020-05-12. It names one FDA 510(k) clearance: K032396. Product: Modular Head Component, Biomet Hip System; Item No. 11-363661, Hip Joint, metal/polymer/metal, semi-constrained, porous-coated, uncemented prosthesis The device is used in treatment of patients who need total hip arthroplasty, and consists of modular components and corresponding instruments.. Reason: Two lots of different sized modular heads potentially commingled. Risks include delay in surgery and dislocation due to use of an incorrect sized head..

Recalling firm: Zimmer Biomet, Inc.
Classification: Class II
Status: Terminated
Initiated: 2018-04-02
Terminated: 2020-05-12
Firm location: Warsaw, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K032396 — RINGLOC 36MM LINE AND MODULAR FEMORAL HEADSBiomet, Inc.·cleared 2003-08-21

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

Modular Head Component, Biomet Hip System; Item No. 11-363661, Hip Joint, metal/polymer/metal, semi-constrained, porous-coated, uncemented prosthesis The device is used in treatment of patients who need total hip arthroplasty, and consists of modular components and corresponding instruments.

Reason for recall

Two lots of different sized modular heads potentially commingled. Risks include delay in surgery and dislocation due to use of an incorrect sized head.

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