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Novation Element Press-Fit, Cementless, HA Coated… recallZ-0201-2016 · Exactech, Inc. · initiated Sep 23, 2015

Class II Terminated All recalls posted in November 2015

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

Eight (8) pieces did not receive the specified Hydroxyapatite (HA) coating.

FDA root cause category: Under Investigation by firm

What the company is doing

The firm, Exactech, issued an "IMPORTANT NOTIFICATION-PRODUCT RECALL ADVISORY NOTICE" dated September 23, 2015, by phone and by mail to their consignees. The notice described the product, problem and actions taken. The consignees were instructed to 1) Immediately cease distribution or use of these products. 2) Extend this information to your accounts that may have this product in their possession. 3) Identify and quarantine any of the subject Novation Element Pres Fit Femoral stem in your inventory. 4) Complete and Return the attached Recall Inventory Response Form to Exactech,per the instructions provided on the notice itself, within 5 business days, via fax to: 352-337-3915 or email [email protected]. Return products to: Exactech Distribution Center, 2411 NW 66th Court, Gainesville, Florida 32653, Attention: Exactech inventory representative. Any questions contact your Exactech inventory representative at [email protected] or 1-800-392-2832.

Recall details

Recall number
Z-0201-2016
Recall class
Class II
Status
Terminated
Initiated by the company
Sep 23, 2015
Posted by the FDA
Nov 2, 2015
Recalling firm
Exactech, Inc.
Quantity
8
Product code
MEH
FDA submissions
K080980
Distribution
US Distribution to states of: AZ, CO, FL, and MD.

Product description

Novation Element Press-Fit, Cementless, HA Coated, Collared, Standard Offset, Size 9, Femoral Hip Implant Stems, Intended for press-fit fixation

Code information (models, lots, serial numbers)

Catalog Number 164-13-09 Serial Numbers: 4076815, 4076816, 4076817, 4076818, 4076819, 4076820, 4076821, and 4076822.

Other devices under the same FDA submission

14 devices cleared under K080980 — 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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