The ATTUNE INTUITION Impaction Handle is a re-useable instrument utilized in knee replacement procedures. The instrument interfaces with several related ATTUNE instruments: keel punch, tibial tower, evaluation bullet, fixed bearing tibial impactor, rotating platform tibial impactor, and femoral impa
Check against the official notice below — it lists the full affected range.
DePuy Orthopaedics is recalling the ATTUNE INTUITION Impaction Handle, a reusable surgical instrument used during knee replacement procedures. Complaints indicate that the instrument's lever can fracture during use. If the lever fractures, pieces of the device or its inner spring could potentially remain inside the patient if not detected during surgery. The recall affects 7,944 units of catalog number 2544-01-017 across all lot numbers, distributed nationwide in the U.S. (except Alaska and Rhode Island), Puerto Rico, and 24 other countries.
The recall covers devices distributed worldwide to facilities in Chile, Canada, Australia, Austria, Belgium, France, Hong Kong, Ireland, India, Israel, Italy, Japan, Malaysia, the Netherlands, New Zealand, Saudi Arabia, Singapore, Slovakia, South Africa, South Korea, Spain, Switzerland, Thailand, the United Arab Emirates, and the United Kingdom. The recall source does not specify a remedy or recommended action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
Complaints have indicated that the ATTUNE INTUITION Impaction Handle lever has fractured during impaction. If the lever fractures, there is the potential for fractured pieces of the device, or the inner spring, if released, to be left in the patient if not observed during surgery.
Reason for recall: Complaints have indicated that the ATTUNE INTUITION Impaction Handle lever has fractured during impaction. If the lever fractures, there is the potential for fractured pieces of the device, or the inner spring, if released, to be left in the patient if not observed during surgery. Distribution: Worldwide Distribution-US (nationwide) except AK and RI, including PR and the countries of Chile, Canada, Australia, Austria, Belgium, France, Hong Kong, Ireland, India, Israel, Italy, Japan, Malaysia, Netherlands, New Zealand, Saudi Arabia, Singapore, Slovakia, South Africa, South Korea, Spain, Switzerland, Thailand, United Arab Emirates (UAE), and United Kingdom (UK Quantity: 7,944 Lot/code info: CATALOG NO. : 2544-01-017 LOT NUMBER: All Lots Barcode GTIN: 10603295423324
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.