Optetrak Asymmetric Hi-Flex Posterior Stabilized Cemented Femorals, size 3, Catalog #244-02-03, Catalog #244-03-03. Usag
FDA device recall Z-0906-2015 · posted 2015-01-05 · Terminated
Recall details
- Recalling firm
- Exactech, Inc.
- Reason for recall
- Mislabeled
- Action taken
- 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.
- Root cause
- Labeling mix-ups
- Status
- Terminated
- Product code
- JWH
- Quantity affected
- 96
- Distribution
- International Distribution only to countries of: Argentina, Austria, Australia, China, Cyprus, France, Greece, India, Japan, Lebanon, The Netherlands, Spain and Tunisia.
- Date initiated
- 2014-10-09
- Date posted
- 2015-01-05
- Date terminated
- 2016-06-08
- Location
- Gainesville, FL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| OPTETRAK TOTAL KNEE SYSTEM, HI-FLEX ASYMMETRIC POSTERIOR-STABILIZED CEMENTED FEMORAL COMPONENTS, HI-FLEX POSTERIOR-STABI (K033883) | Exactech, Inc. | 2004-02-13 |