Zimmer Biomet, Inc.: Medical Device Recall in 2018 - (Recall #: Z-0535-2019)

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:

Zimmer ZMS¿ Intramedullary Fixation Smooth Guide Wire - Bullet Tip, 3.0 mm Diameter, 100 cm Length Item Number: 47-2237-038-00 Product Usage: A single use surgical instrument used during orthopaedic surgery for implantation of a prosthesis.

Product Classification:

Class II

Date Initiated: October 22, 2018

Date Posted: December 12, 2018

Recall Number: Z-0535-2019

Event ID: 81394

Reason for Recall:

Various Trauma Guide Wires- creases in the sealing area on the end opposite of the product's chevron opening compromising product sterility

Status: Terminated

Product Quantity: 3358

Code Information:

All lots expiring prior to September 30, 2023

Distribution Pattern:

Worldwide - US Nationwide Distribution Foreign: CANADA AUSTRALIA BRAZIL CHILE HONG KONG JAPAN MALAYSIA NETHERLANDS NICARAGUA SINGAPORE TAIWAN

Voluntary or Mandated:

Voluntary: Firm initiated