The Persona Tibial Articular Surface Inserter is a sterilizable instrument intended for use in multiple total knee arthr
FDA device recall Z-0123-2015 · posted 2014-10-23 · Terminated
Recall details
- Recalling firm
- Zimmer, Inc.
- Reason for recall
- Affected product did not undergo heat treatment hardening step leading to the potential for deformation of the tip.
- Action taken
- Zimmer sent an " URGENT MEDICAL DEVICE RECALL - LOT SPECIFIC " notifications dated September 2014, to all affected customers. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. If after reviewing this notification you have further questions or concerns please call the customer call center at 1-877-946-2761 between 8:00 am and 5:00pm EST.
- Root cause
- Process control
- Status
- Terminated
- Product code
- JWH
- Quantity affected
- 618 units
- Distribution
- Worldwide Distribution - USA (nationwide) including the states of NY, OR, NC, OH, TX, FL, CO, IN, TN, PA, CA, KS, MO, WI, VA, MN, NJ, UT, MA, GA, MI, OK, AZ, MS, IL and AL., and the countries of Korea
- Date initiated
- 2014-10-07
- Date posted
- 2014-10-23
- Date terminated
- 2015-09-23
- 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 |
|---|---|---|
| ZIMMER PERSONA KNEE SYSTEM (K113369) | Zimmer, Inc. | 2012-03-27 |