—#108097

Product

DePuy Attune Impaction Handle Warsaw, IN 46582 Packaging: Product is packed within a polyethylene bag, with protection added as needed for sharp and/or fragile points. Product Usage: The ATTUNE Impaction handle is intended to act as a removable interface for several of the instruments that may be used throughout a procedure. The Attune Impaction Handle is used to impact, insert, and extract various Attune Instruments. The handle interfaces with the Keel Punch, Tibial Tower, Evaluation Bullet, Fixed Bearing Tibial Impactor, Rotating Platform Tibial Impactor and the Femoral Impactor.

FDA product code: LXH — Orthopedic Manual Surgical Instrument
Device class: Class 1
Medical specialty: Orthopedic
Affected lot / code info: Catalog: 254401010 Lot numbers: NW102815, NW102817, NW102816, NW102812, NW102814, NW102818, NW102819, NW102820, and NW104367.

Why it was recalled

DePuy Orthopaedics, Inc. is issuing a Recall Notice for nine lots of the Attune" Impaction Handle due to the potential for the handle trigger to break during surgery. The Attune Impactor is provided as a part of a set of tools and is designed specifically for the installation of the Attune Knee

Root cause (FDA determination)

Device Design

Action the firm took

DePuy Orthopaedics, Inc. sent an URGENT INFORMATION - MEDICAL DEVICE RECALL NOTICE letter dated March 16, 2012 to all consignees affected which extended to the Depuy Distributor level, surgeon and hospital level. The affected DePuy Distributors were notified via email on March 16, 2012. The sales representatives notify hospitals and surgeons by mail or in person with written communication. The letter identified the affected product, reason for recall notice, clinical implications and actions to be taken. Consignees were instructed to complete and return the Response cards to DePuy by fax to 574-372-7567 or email to:kseppa@its.jnj.com. When the new impaction handles are available, the DePuy sales representative will be responsible for providing the new handles, removing and returning the affected handles. For product-related questions, please contact your local DePuy Orthopaedics sales representative. For clinical-related questions from surgeons, please contact DePuy's Scientific Information Office at 1-888-554-2482 (M-F; 8 am - 5 pm EST.) For questions about recall information provided, please contact Katie Seppa, Manager of Customer Quality, 574-372-7333 (M-F; 8 am - 5 pm EST.)

Recalling firm

Firm: DePuy Orthopaedics, Inc.
Address: 700 Orthopaedic Dr, Warsaw, Indiana 46582-3994

Distribution

Distribution pattern: USA Nationwide Distribution including the states of: MA, MD, IL, IA, MN, WA, CA, FL, NC, VA, and IN.

Timeline

Recall initiated: 2012-03-16
Posted by FDA: 2012-04-16
Terminated: 2014-01-09
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #108097. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.