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High RiskFDAfda-Z-0572-2020STERILITY ISSUE

SWANSON TRAPEZIUM IMPLANT, Part Number 4520002

Units Affected
20
Recall Date
November 8, 2016
Issuing Agency
Hazard
Sterility Issue

FDA Recall Notice

Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0572-2020.

The firm discovered a lack of adequate documentation confirming sterility on certain products.

Corrective Action (per FDA)

Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0572-2020.

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 Wright Medical Technology, 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-0572-2020.

Wright Medical Technology, Inc.

FDA

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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.

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Wright Medical Technology, Inc. Recall FAQ

Wright Medical Technology, Inc. is the subject of a medical implants safety report: SWANSON TRAPEZIUM IMPLANT, Part Number 4520002. The notice was published on November 8, 2016 by the U.S. Food and Drug Administration (FDA). Approximately 20 units are potentially affected.