Skip to main content
High RiskFDAfda-Z-0531-2019STERILITY ISSUE

Zimmer M/DN¿ Intramedullary Fixation Humeral Guide Wire - Smooth, 2.4 mm Diameter, 70 cm Length Item Number: 00-2255-025-00 Product U...

Units Affected
4,122
Recall Date
October 22, 2018
Issuing Agency
Hazard
Sterility Issue

FDA Recall Notice

Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0531-2019.

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

Corrective Action (per FDA)

Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0531-2019.

Recall terminated by FDA.

✅ What you should do

  1. Stop using the product if you own it.
  2. Check the model number, lot code, or sell-by date against the recall notice above.
  3. Contact Zimmer Biomet, Inc. or the retailer where you bought it for a refund, replacement, or repair.
  4. For the most current official instructions, visit the FDA recall page.
  5. If you've been hurt by this product, report the incident to FDA.

Consumer Contact (per FDA)

Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0531-2019.

Zimmer Biomet, Inc.

FDA

About the U.S. Food and Drug Administration

The FDA regulates drugs, medical devices, food, cosmetics, and tobacco. Adverse event reports and recall notices are the main public safety signal.

Visit FDA.gov →

📣 Report a food, supplement, or cosmetic problem to the FDA

If you had a reaction, found contamination, or experienced a labeling problem with this product, report it to the FDA. The agency uses consumer reports to track emerging safety signals and trigger recalls.

How to report to FDAFile a report at FDA

Zimmer Biomet, Inc. Recall FAQ

Zimmer Biomet, Inc. is the subject of a medical implants safety report: Zimmer M/DN¿ Intramedullary Fixation Humeral Guide Wire - Smooth, 2.4 mm Diameter, 70 cm Length Item Number: 00-2255-025-00 Product U.... The notice was published on October 22, 2018 by the U.S. Food and Drug Administration (FDA). Approximately 4,122 units are potentially affected.