—#160913

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.

FDA product code: MEH — Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K162732
Affected lot / code info: 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.

Why it was recalled

Wrong device description of the label identifying the implant

Root cause (FDA determination)

Error in labeling

Action the firm took

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.

Recalling firm

Firm: Exactech, Inc.
Address: 2320 NW 66th Ct, Gainesville, Florida 32653-1630

Distribution

Distribution pattern: US Distribution to the states of : AL, CA, CO, FL, MD. and NY

Timeline

Recall initiated: 2017-10-09
Posted by FDA: 2018-01-18
Terminated: 2019-08-06
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #160913. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.