Zimmer Biomet, Inc.: Medical Device Recall in 2018 - (Recall #: Z-1538-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: April 2, 2018

Date Posted: May 9, 2018

Recall Number: Z-1538-2018

Event ID: 79685

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.

Status: Terminated

Product Quantity: 18

Code Information:

lot 299340

Distribution Pattern:

Worldwide Distribution: US (nationwide) in states of: AL, AR, FL, GA, IN, KY, LA, MO, MS, OH, OK, TX, and VA; and countries of: Canada, Costa Rica and Chile.

Voluntary or Mandated:

Voluntary: Firm initiated