Home / Recalls / DePuy Orthopaedics, Inc. / Z-0905-2015

Z-0905-2015 Class II Terminated

Recalled by DePuy Orthopaedics, Inc. — Warsaw, IN

FDA device recall Z-0905-2015 was initiated by DePuy Orthopaedics, Inc. on Nov 10, 2014 and is designated Class II. 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… The recall status is terminated (terminated Dec 8, 2015). Affected quantity: 4661.

Recall Details

Product Type: Devices
Report Date: Jan 14, 2015
Initiation Date: Nov 10, 2014
Termination Date: Dec 8, 2015
Voluntary/Mandated: Voluntary: Firm initiated
Product 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).

Code Information

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

Source

Dataset: openFDA device recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for Z-0905-2015
openFDA file date: Oct 23, 2026
Loaded by RegDataLab: Oct 26, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

Other recalls by DePuy Orthopaedics, Inc.

Z-1456-2024 Class II — ATTUNE AFFIXIUM Cementless Fixed Bearing Knee with 3DP Technology, Size 6… (Mar 12, 2024)
Z-1265-2023 Class II — Attune Revision Limb Preservation System (LPS) Tibial Insert XSM 26MM, Part… (Feb 15, 2023)
Z-1263-2023 Class II — Attune Revision Limb Preservation System (LPS) Tibial Insert XXSM 18MM, Part… (Feb 15, 2023)
Z-1264-2023 Class II — Attune Revision Limb Preservation System (LPS) Tibial Insert XSM 12MM, Part… (Feb 15, 2023)
Z-1267-2023 Class II — Attune Posterior (PS) Fixed Bearing (FB) Tibial Insert SZ5 7MM, Part Number… (Feb 15, 2023)
Z-1266-2023 Class II — Attune Revision Limb Preservation System (LPS) Tibial Insert SM 12MM, Part… (Feb 15, 2023)
Z-1419-2022 Class II — ATTUNE Measured Sizing and Rotation Guide-to size the femur and align rotation… (Jun 29, 2022)
Z-1375-2022 Class II — MODULAR CATHCART FRACTURE HEAD HIP BALL, sizes 41mm to 60mm inclusive; metallic… (May 18, 2022)
Z-1029-2022 Class II — VELYS Robotic-Assisted Solution Base Product No.: 451570100 (Mar 11, 2022)
Z-0632-2022 Class II — ATTUNE REVISION DISTAL FEMORAL AUGMENT SZ 6 4MM- Intended as a Component in… (Jan 5, 2022)