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:
Check against the official notice below — it lists the full affected range.
DePuy Orthopaedics, Inc. has recalled 4,555 ATTUNE INTUITION Impactors (catalog numbers 254401003, 254401004, and 254401006) used as reusable instruments during knee replacement procedures. These impactors have been found to break and produce small pieces. If fracturing occurs during surgery without being detected, fractured pieces of the instrument could potentially remain inside the patient's body. The impactors were distributed worldwide, including throughout the United States (except Alaska and Rhode Island) and to 23 other countries.
The recall record does not specify a remedy or recommended 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: 4555 Lot/code info: CATALOG NO. : ATTUNE INTUITION Impactors Fixed Tibial Bearing, (254401003) Barcode GTIN Number: Fixed Tibial Bearing, ......... 10603295130192 ALL LOTS
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.