Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
P.F.C. SIGMA Revision Knee System Distal Augment Recalled by DePuy Orthopaedics, Inc. Due to This unit may be missing the screw/collet Assembly
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 DePuy Orthopaedics, Inc. directly.
Affected Products
P.F.C. SIGMA Revision Knee System Distal Augment, Model Number 960830
Quantity: 1
Why Was This Recalled?
This unit may be missing the screw/collet Assembly
Where Was This Sold?
The devices were not distributed in the United States. The devices were distributed to the following foreign countries: Great Britain.
About DePuy Orthopaedics, Inc.
DePuy Orthopaedics, Inc. has 154 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report