Femoral Impactor ATTUNE INTUITION Impactor. The ATTUNE INTUITION Impactors are re-useable instru...

FDA Device Recall #Z-0905-2015 — Class II — November 10, 2014

Recall Summary

Recall Number Z-0905-2015
Classification Class II — Moderate risk
Date Initiated November 10, 2014
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm DePuy Orthopaedics, Inc.
Location Warsaw, IN
Product Type Devices
Quantity 4661

Product Description

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).

Reason for Recall

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.

Distribution Pattern

Worldwide Distribution: US (nationwide) including P.R. except AK and RI; and Internationally to: Chile, Canada, Australia, Austria, Belgium, China, France, Ireland, India, Israel, Italy, Japan, Malaysia, Netherlands, New Zealand, Singapore, Slovakia, South Africa, South Korea, Spain, Switzerland, Thailand, United Arab Emirates (UAE), and United Kingdom (UK).

Lot / Code Information

CATALOG NO. : ATTUNE INTUITION Impactors Femoral Impactor, (254401006) Barcode GTIN Number: Femoral Impactor, 10603295130222 ALL LOTS

Other Recalls from DePuy Orthopaedics, Inc.

Recall # Classification Product Date
Z-1456-2024 Class II ATTUNE AFFIXIUM Cementless Fixed Bearing Knee w... Mar 12, 2024
Z-1264-2023 Class II Attune Revision Limb Preservation System (LPS) ... Feb 15, 2023
Z-1267-2023 Class II Attune Posterior (PS) Fixed Bearing (FB) Tibial... Feb 15, 2023
Z-1263-2023 Class II Attune Revision Limb Preservation System (LPS) ... Feb 15, 2023
Z-1266-2023 Class II Attune Revision Limb Preservation System (LPS) ... Feb 15, 2023

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.