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Alteon HA Femoral Stem, Press-Fit, Extended Offset… recallZ-0538-2018 · Exactech, Inc. · initiated Oct 9, 2017

Class II Terminated All recalls posted in January 2018

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Exactech, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Wrong device description of the label identifying the implant

FDA root cause category: Error in labeling

What the company is doing

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.

Recall details

Recall number
Z-0538-2018
Recall class
Class II
Status
Terminated
Initiated by the company
Oct 9, 2017
Posted by the FDA
Jan 18, 2018
Recalling firm
Exactech, Inc.
Quantity
34
Product code
MEH
FDA submissions
K162732
Distribution
US Distribution to the states of : AL, CA, CO, FL, MD. and NY

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.

Code information (models, lots, serial numbers)

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.

Other devices under the same FDA submission

27 devices cleared under K162732 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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