Reported Apr 26, 2023 · Ongoing

JOURNEY II UNI XLPE TIBIA INSERT MEDIAL SZ 7-8 8MM

Smith & Nephew, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Smith & Nephew, Inc. · 1450 E Brooks Rd · Memphis, TN · 38116-1804

Is this the product you have?

  • JOURNEY II UNI XLPE TIBIA INSERT MEDIAL SZ 7-8 8MM
Lot codes and dates
  • Catalog Number74026178
  • UDI/DI00885556677209
  • Batch Number22CAP0038R
  • Lot Number22CAP0038R
Amount recalled
12 units

Where it was sold

Why it was recalled

A mispack occurred during the manufacturing process, resulting in the box incorrectly containing JOURNEY II UNI Tibia Insert Medical Size 1-2 12MM instead of the JOURNEY II UNI Tibia Insert Medial Size 7-8 8MM.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 5:42 PM UTC

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