Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Femoral Impactor ATTUNE INTUITION Impactor. The ATTUNE INTUITION Impactors are Recalled by DePuy Orthopaedics, Inc. Due to ATTUNE INTUITION Impactors (cat. nos. 254401003, 254401004, and...
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
Femoral Impactor ATTUNE INTUITION Impactor. The ATTUNE INTUITION Impactors are re-useable instruments utilized in knee replacement procedures. The three affected impactors are used at various times within the surgical flow, each impactor is used to impact and drive home its relevant mating part: Fixed Tibial bearing, (254401003) Rotating Tibial Platform, (254401004) and Femoral impactor, (254401006).
Quantity: 4661
Why Was This Recalled?
ATTUNE INTUITION Impactors (cat. nos. 254401003, 254401004, and 254401006) have broken and produced small pieces. Should a fracture occur and not be observed during surgery, there is the potential for these small fractured pieces of the instrument to be left in the patient.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
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