Z-0906-2015 Class II Terminated
FDA device recall Z-0906-2015 was initiated by Exactech, Inc. on Oct 9, 2014 and is designated Class II. Reason for recall: Mislabeled The recall status is terminated (terminated Jun 8, 2016). Affected quantity: 96.
Recall Details
- Product Type
- Devices
- Report Date
- Jan 14, 2015
- Initiation Date
- Oct 9, 2014
- Termination Date
- Jun 8, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 96
Product Description
Optetrak Asymmetric Hi-Flex Posterior Stabilized Cemented Femorals, size 3, Catalog #244-02-03, Catalog #244-03-03. Usage:Femoral implants
Reason for Recall
Mislabeled
Distribution Pattern
International Distribution only to countries of: Argentina, Austria, Australia, China, Cyprus, France, Greece, India, Japan, Lebanon, The Netherlands, Spain and Tunisia.
Code Information
Catalog #244-02-03, Serial # 2925147 - 2925194; Catalog #244-03-0, Serial #2925246 - 2925293.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0906-2015
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026