Skip to main content
High RiskFDAfda-Z-1467-2023OTHER

stryker ORTHOLOC 3Di Fusion Plate MTP Right, REF 58A221RT, bone stabilization and fixation

Units Affected
50
Recall Date
April 10, 2023
Issuing Agency
Hazard
Other

FDA Recall Notice

Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-1467-2023.

Two lots of Ortholoc 3Di Fusion plates contain incorrect dorsiflexion descriptions laser marked on the parts.

Corrective Action (per FDA)

Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-1467-2023.

Recall ongoing. Follow firm instructions.

🩺 Talk to your doctor or pharmacist

Product Recall Tracker does not provide medical advice. Any specific instructions about this medication or device come directly from the FDA notice above. Before making any change to your treatment:

  1. Do not stop, change, or discard your prescription on your own.
  2. Call your doctor or pharmacist and ask whether this FDA notice applies to your prescription (have the brand name, dosage, and lot number ready if you can find them).
  3. Follow your clinician's guidance on whether to continue, switch, or return the product.
  4. If you have experienced a reaction, seek medical care and report it to the FDA via MedWatch.
  5. For the official FDA notice, visit the FDA recalls page.

Consumer Contact (per FDA)

Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-1467-2023.

Wright Medical Technology, 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 an adverse event to the FDA (MedWatch)

If you had an adverse reaction, side effect, or device malfunction from this medication or device, report it to the FDA through MedWatch. Talk to your doctor or pharmacist first — do not stop a prescription on your own. Reports help the FDA detect rare or emerging safety signals and can lead to label changes or recalls.

How to report to FDAFile a report at FDA

Wright Medical Technology, Inc. Recall FAQ

Wright Medical Technology, Inc. is the subject of a medical devices safety report: stryker ORTHOLOC 3Di Fusion Plate MTP Right, REF 58A221RT, bone stabilization and fixation. The notice was published on April 10, 2023 by the U.S. Food and Drug Administration (FDA). Approximately 50 units are potentially affected.