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: Fix
Check against the official notice below — it lists the full affected range.
DePuy Orthopaedics is recalling ATTUNE INTUITION Femoral Impactors (catalog numbers 254401003, 254401004, and 254401006), which are reusable instruments used during knee replacement procedures. These impactors have been found to break and produce small pieces. If a fracture occurs during surgery but goes unnoticed, the small fractured pieces could potentially remain inside the patient's body.
A total of 4,661 affected impactors were distributed worldwide, including throughout the United States (except Alaska and Rhode Island) and to countries including Canada, Australia, Japan, South Korea, and the United Kingdom, among others. The recall record does not specify what affected consumers should do in response to this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
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: 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). Quantity: 4661 Lot/code info: CATALOG NO. : ATTUNE INTUITION Impactors Femoral Impactor, (254401006) Barcode GTIN Number: Femoral Impactor, 10603295130222 ALL LOTS
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.