Class II — Potential Health Hazard

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

Identity Imprint PS Tibial Tray Size 4: Lot 540287 Recalled by Conformis, Inc. Due to Size 5 Tibial Tray from Lot 508287 was...

Date: March 11, 2024
Company: Conformis, 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 Conformis, Inc. directly.

Affected Products

Identity Imprint PS Tibial Tray Size 4: Lot 540287

Quantity: 3 units

Why Was This Recalled?

Size 5 Tibial Tray from Lot 508287 was packaged in a Size 4 box from Lot 540287. It was confirmed that Lot 540287 and Lot 508287 were swapped between the pouching and final pack.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Conformis, Inc.

Conformis, Inc. has 16 total recalls tracked by RecallDetector.

Related Recalls

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