FDA Medical Device Recalls (openFDA)
Exactech, Inc.: 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.
- Recall number
- Z-0538-2018
- Recalling firm
- Exactech, Inc.
- Product
- 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.
- Status
- Terminated
- Initiated
- 2017-10-09
- Posted
- 2018-01-18
- Terminated
- 2019-08-06
- Reason
- Wrong device description of the label identifying the implant
- Root cause
- Error in labeling
- Action
- Exactech sent an Urgent Medical Device Recall letter dated October 9, 2017, informing them of the potential mislabel. The notice requested consignees: Immediately cease distribution/use of this product; Extend information to accounts in possession of the product; Identify and quarantine any subject devices in their inventory; Complete and return Recall Acknowledgement and Recall Inventory Response Forms. For further questions, please call (800) 392-2832.
- Quantity
- 34
- Distribution
- US Distribution to the states of : AL, CA, CO, FL, MD. and NY
- Lot, serial or model codes
- 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.
- 510(k) numbers
- ["K162732"]
- PMA numbers
- not on file
- Product code
- MEH
- Firm FEI
- 1038671
- Firm city
- Gainesville
- Firm state
- FL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28