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Optetrak Asymmetric Hi-Flex Posterior Stabilized Cemented… recallZ-0906-2015 · Exactech, Inc. · initiated Oct 9, 2014

Class II Terminated All recalls posted in January 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

Mislabeled

FDA root cause category: Labeling mix-ups

What the company is doing

The firm, Exactech, sent an "Urgent Field Safety Notice" letter dated September 30, 2014 to its Consignees/customers by electronic mail on October 9, 2014. The letter described the product, problem and actions to be taken. The customers were instructed to: immediately cease distribution or use of the products; extend information to your accounts that may have this product in their possession; verify whether you have any of the subject femoral components from the specified serial number ranges; complete and return the attached inventory RESPONSE FORM via fax to: 011 61 2 9638 0778 within 48 hrs of receipt of the notice, and contact your Exactech representative to confirm quantities at your location and arrangements for product return and inventory restocking. If you have any questions, contact Manager, Regulatory Affairs at 352-377-1140.

Recall details

Recall number
Z-0906-2015
Recall class
Class II
Status
Terminated
Initiated by the company
Oct 9, 2014
Posted by the FDA
Jan 5, 2015
Recalling firm
Exactech, Inc.
Quantity
96
Product code
JWH
FDA submissions
K033883
Distribution
International Distribution only to countries of: Argentina, Austria, Australia, China, Cyprus, France, Greece, India, Japan, Lebanon, The Netherlands, Spain and Tunisia.

Product description

Optetrak Asymmetric Hi-Flex Posterior Stabilized Cemented Femorals, size 3, Catalog #244-02-03, Catalog #244-03-03. Usage:Femoral implants

Code information (models, lots, serial numbers)

Catalog #244-02-03, Serial # 2925147 - 2925194; Catalog #244-03-0, Serial #2925246 - 2925293.

Other devices under the same FDA submission

72 devices cleared under K033883 — 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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