Device product
Optetrak Asymmetric Hi-Flex Posterior Stabilized Cemented Femorals, size 3, Catalog #244-02-03, Catalog #244-03-03. Usage:Femoral implants
Z-0906-2015
Product summary
- Firm
- Exactech, Inc.
- Event
- Event 69466
- Status
- Terminated
- Classification
- Class II
- Quantity
- 96
- Official record key
device-enforcement:Z-0906-2015
Official wording
Reason: Mislabeled
Code information: Catalog #244-02-03, Serial # 2925147 - 2925194; Catalog #244-03-0, Serial #2925246 - 2925293.
Distribution pattern: International Distribution only to countries of: Argentina, Austria, Australia, China, Cyprus, France, Greece, India, Japan, Lebanon, The Netherlands, Spain and Tunisia.
Derived failure modes
-
Labeling or packaging
Mislabeled