Recall Z-1424-2012 ยท LXH Orthopedic Manual Surgical Instrument
DePuy Orthopaedics, Inc.
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 vari
| Date | Apr 16, 2012 (initiated Mar 16, 2012) |
| Status | Terminated |
| Reason | 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 | Device Design |
| Action | 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 t |
| Quantity | 136 impaction handles |
| Distribution | USA Nationwide Distribution including the states of: MA, MD, IL, IA, MN, WA, CA, FL, NC, VA, and IN. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.