Z-0538-2018 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- February 14, 2018
- Initiation Date
- October 9, 2017
- Termination Date
- August 6, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 34
Product Description
Alteon HA Femoral Stem, Press-Fit, Extended Offset, Cementless, HA Coated, Collared, Size 5 All Exactech Hip Systems are indicated for use in skeletally mature individuals undergoing primary surgery for hip replacement due to osteoarthritis, rheumatoid arthritis, osteonecrosis, post-traumatic degenerative problems of the hip, and for treatment of proximal femoral fractures where prosthetic replacement is determined by the surgeon as the preferred treatment. Components of Exactech Hip Systems are also potentially indicated for ankylosing spondylitis, congenital hip dysplasia, revision of failed previous reconstructions where sufficient bone stock is present, and to restore mobility resulting from previous fusion. Exactech Alteon HA femoral stems are intended for press-fit fixation.
Reason for Recall
Wrong device description of the label identifying the implant
Distribution Pattern
US Distribution to the states of : AL, CA, CO, FL, MD. and NY
Code Information
Catalog #: 190-30-05 Serial#'s: 4897288, 4897291, 4897293, 4907465, 4907466, 4907467, 4907469, 4907472, 4907475, 4907476, 4907477, 4907478, 4907479, 4907481, 4943094, 4943095, 4943096, 4943097, 4943102, 4943104, 4943105, 4943106, 4984977, 4984978, 4984979, 4984980, 4984981, 4984982, 5046901, 5046902, 5046903, 5046904, 5046905, and 5046906.