Reported Jul 12, 2023 · Ongoing

Stryker Infinity Alignment Frame Distal Sub-Assembly, Catalog #33600020, non-sterile.

Wright Medical Technology, 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: Wright Medical Technology, Inc. · 1023 Cherry Rd · Memphis, TN · 38117-5423

Is this the product you have?

  • Stryker Infinity Alignment Frame Distal Sub-Assembly, Catalog #33600020, non-sterile.
Lot codes and dates
    • Lot numbers 2656815 and 2762126
    • UDI-DI 00889797003926
Amount recalled
106 devices

Why it was recalled

The devices were manufactured with the pin sleeve holes too narrow, which does not allow the pin sleeves to pass through the pin sleeve holes, thereby preventing pin placement through the pin holes.

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, 4:54 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.