NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Component, Precoat, Fixed Bearing, Size 4+. Part
FDA device recall Z-1935-2014 · posted 2014-06-27 · Terminated
Recall details
- Recalling firm
- Zimmer, Inc.
- Reason for recall
- Zimmer is initiating a voluntary recall of specific identified lots due to the potential that the threads may be out of specification.
- Action taken
- Zimmer sent an Urgent Medical Device Recall letter June 2014 to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to review the notification and ensure affected personnel are aware of the contents. Locate and quarantine any affected product and notify their Zimmer sales representative. Their Zimmer sales representative will remove the recalled product from their facility. For patients that previously had this product implanted, it is recommended that they continue their normal operative follow up routine. Customers with questions were instructed to call 1-877-946-2761.
- Root cause
- Equipment maintenance
- Status
- Terminated
- Product code
- JWH
- Quantity affected
- 41,180 total
- Distribution
- Worldwide Distribution - USA (nationwide) and Internationally to Australia, China, Hong Kong, India, Japan, Korea, Malaysia, Nicaragua, Singapore, and Taiwan.
- Date initiated
- 2014-05-19
- Date posted
- 2014-06-27
- Date terminated
- 2015-10-29
- Location
- Warsaw, IN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| NEXGEN COMPLETE KNEE SOLUTION MIS TIBIAL COMPONENTS, LOCKING SCREW AND STEM EXTENSIONS (K043101) | Zimmer, Inc. | 2005-03-07 |