Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Stryker Infinity Alignment Frame Distal Sub-Assembly Recalled by Wright Medical Technology, Inc. Due to The devices were manufactured with the pin sleeve...

Date: June 13, 2023
Company: Wright Medical Technology, Inc.
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Wright Medical Technology, Inc. directly.

Affected Products

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

Quantity: 106 devices

Why Was This 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.

Where Was This Sold?

There was no U.S. distribution, including government and military. Foreign distribution was made to Australia, Belgium, Canada, Chile, China, Colombia, France, Germany, Italy, Mexico, Netherlands, Spain, Sweden, Switzerland, Taiwan, and the United Kingdom.

About Wright Medical Technology, Inc.

Wright Medical Technology, Inc. has 69 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report