Recall Z-1820-2013 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
DePuy Orthopaedics, Inc.
LPS Lower Extremity Dovetail Intercalary component. Intended for use in replacement of the mid-shaft portion of the femur.
| Date | Jul 31, 2013 (initiated Jul 11, 2013) |
| Status | Terminated |
| Reason | The LPS Lower Extremity Dovetail Intercalary component has the potential for fracture of the female component when exposed to certain physiological loads. |
| Root cause | Device Design |
| Action | On 7/11/13, URGENT MEDICAL DEVICE RECALL NOTIFICATIONS were sent to consignees: Depuy Distributors, hospitals, and surgeons. End-user Hospital Customers will submit reconciliation forms to DePuy. Possible clinical implications of device failure are stated in these notifications, including poor mechanics and loss of function, pain, component dislocation, adverse tissue reaction, bone damage, potential need for revision surgery and the risks associated with this type of surgery. A patient letter will be included with the surgeon letter to assist in surgeon's notification and discussion with pa |
| Quantity | 58 U.S. / 39 OUS |
| Distribution | Worldwide Distribution-USA including the states of FL, GA, ID, KS, KY, MI, MO, NC, NV, NY, OH, OK, PA, TN, TX, VA, and WA and the countries of AUSTRALIA, CANADA, ENGLAND, GERMANY, INDIA, COUNTY CORK, IRELAND, and TURKEY. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K041085 | LPS (LIMB PRESERVATION SYSTEM) LOWER EXTREMITY DOVETAIL INTERCALARY Depuy, Inc., Jul 22, 2004 |