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Alteon recallZ-0578-2024 · Exactech, Inc. · initiated Nov 21, 2023

Open, Classified

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

Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.

FDA root cause category: Packaging change control

What the company is doing

Exactech issued an URGENT MEDICAL DEVICE RECALL notice to its direct consignees on 11/21/2023 via email. The notice explained the issue, clinical impact, and requested the removal and return of all affected products. 11/22/2023, the firm initiated the recall OUS also by email.

Recall details

Recall number
Z-0578-2024
Status
Open, Classified
Initiated by the company
Nov 21, 2023
Posted by the FDA
Jan 18, 2024
Recalling firm
Exactech, Inc.
Product code
LPH
FDA submissions
K182502
Distribution
US NY, TX, IN, IL, MN, KY, VA, MD, TN, GA, NH, ME, SC, NV, FL, AR and Australia, Brazil, Chile, France, Germany, Guatemala, Italy, Japan, Korea, Slovenia, Spain, UK

Product description

Exactech Alteon Hip XLE Liner, Catalog Numbers: a) 01-030-40-0636, b) 01-030-40-0640, c) 01-030-42-0536

Code information (models, lots, serial numbers)

a) 01-030-40-0636, GTIN 10885862549655, Serial Numbers: A678476, A678485, A678486, A678495, A678508, A678516, A678819, A678820, A678822, A678826, A678827, A678832, A678845, A678847, A678855, A678859, A678863; b) 01-030-40-0640, GTIN 10885862549662, Serial Numbers: A746645, A746649; c) 01-030-42-0536, GTIN 10885862549945, Serial Numbers: A655570, A655573, A655574

Devices named in this recall

3 devices in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

85 devices cleared under K182502 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 93507).

Sources and updates

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