Home / Recalls / DePuy Orthopaedics, Inc. / Z-0903-2015

Z-0903-2015 Class II Terminated

Recalled by DePuy Orthopaedics, Inc. — Warsaw, IN

FDA device recall Z-0903-2015 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: 4555.

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: 4555

Product Description

Fixed Tibial bearing 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 Fixed Tibial Bearing, (254401003) Barcode GTIN Number: Fixed Tibial Bearing, ......... 10603295130192 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-0903-2015
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.

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