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 p
Check against the official notice below — it lists the full affected range.
DePuy Orthopaedics, Inc. is recalling ATTUNE INTUITION Impactors (catalog numbers 254401003, 254401004, and 254401006), which are reusable instruments used during knee replacement surgery. These impactors have been found to break and produce small fragments. If a fracture occurs during surgery and is not detected, the broken pieces could potentially remain inside the patient's body. A total of 3,861 units have been distributed worldwide.
The affected impactors were distributed throughout the United States (except Alaska and Rhode Island) and internationally to 24 countries including Canada, Australia, Japan, the United Kingdom, and others. The recall notice does not specify a remedy or corrective action for affected consumers.
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: 3861 Lot/code info: CATALOG NO. : ATTUNE INTUITION Impactors Rotating Tibial Platform, (254401004) Barcode GTIN Number: Rotating Tibial Platform, ......... 10603295130208 ALL LOTS
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.