Novation Element Press-Fit, Cementless, HA Coated, Collared, Standard Offset, Size 9, Femoral Hip Implant Stems, Intende
FDA device recall Z-0201-2016 · posted 2015-11-02 · Terminated
Recall details
- Recalling firm
- Exactech, Inc.
- Reason for recall
- Eight (8) pieces did not receive the specified Hydroxyapatite (HA) coating.
- Action taken
- The firm, Exactech, issued an "IMPORTANT NOTIFICATION-PRODUCT RECALL ADVISORY NOTICE" dated September 23, 2015, by phone and by mail to their consignees. The notice described the product, problem and actions taken. The consignees were instructed to 1) Immediately cease distribution or use of these products. 2) Extend this information to your accounts that may have this product in their possession. 3) Identify and quarantine any of the subject Novation Element Pres Fit Femoral stem in your inventory. 4) Complete and Return the attached Recall Inventory Response Form to Exactech,per the instructions provided on the notice itself, within 5 business days, via fax to: 352-337-3915 or email kaya@exac.com. Return products to: Exactech Distribution Center, 2411 NW 66th Court, Gainesville, Florida 32653, Attention: Exactech inventory representative. Any questions contact your Exactech inventory representative at kaya@exac.com or 1-800-392-2832.
- Root cause
- Under Investigation by firm
- Status
- Terminated
- Product code
- MEH
- Quantity affected
- 8
- Distribution
- US Distribution to states of: AZ, CO, FL, and MD.
- Date initiated
- 2015-09-23
- Date posted
- 2015-11-02
- Date terminated
- 2017-03-01
- 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 |
|---|---|---|
| EXACTECH NOVATION ELEMENT PRESS-FIT FEMORAL STEMS (K080980) | Exactech, Inc. | 2008-05-06 |