Omnilife Science Apex Knee System Modular Tibia Augment, Size 2 x 4mm Ref: KC-54020. The Apex Knee System is intended fo
FDA device recall Z-2371-2012 · posted 2012-09-13 · Terminated
Recall details
- Recalling firm
- Omni Life Science
- Reason for recall
- The Apex Knee System Modular Tibia Augment may breach the inner and outer sterile pouches, compromising the sterility
- Action taken
- Omnilife Science contacted affected customers by phone and sent an "URGENT MEDICAL DEVICE RECALL" e-mail on August 9, 2012. The e-mail identifies the product, problem, and actions to be taken by the customers. Customers with questions regarding product return should contact Customer Service at 800-448-6664. Customers with questions regarding the recall should contact the firm at 774-226-1845.
- Root cause
- Packaging
- Status
- Terminated
- Product code
- JWH
- Quantity affected
- 286 units
- Distribution
- Worldwide Distribution-USA (nationwide including the states of CO, NY, OK, PA, UT, VA, and WI, and the countries of Spain and the Netherlands.
- Date initiated
- 2012-08-09
- Date posted
- 2012-09-13
- Date terminated
- 2013-01-10
- Location
- East Taunton, MA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| TIBIAL BASEPLATE AUGMENT MODEL KC-22118, KC-22128, KC-22138, KC-22148, KC-22158 (K094017) | Omni Life Science, Inc. | 2010-03-05 |