DePuy Orthopaedics, Inc.: Medical Device Recall in 2015 - (Recall #: Z-0904-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

Rotating Tibial Platform 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).

Product Classification:

Class II

Date Initiated: November 10, 2014

Date Posted: January 14, 2015

Recall Number: Z-0904-2015

Event ID: 70043

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.

Status: Terminated

Product Quantity: 3861

Code Information:

CATALOG NO. : ATTUNE INTUITION Impactors Rotating Tibial Platform, (254401004) Barcode GTIN Number: Rotating Tibial Platform, ......... 10603295130208 ALL LOTS

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).

Voluntary or Mandated:

Voluntary: Firm initiated