Persona The Personalized Knee System Articular Surface Posterior Stabilized (PS) Left Height 18mm Sterile For use in tot
FDA device recall Z-1341-2016 · posted 2016-04-06 · Terminated
Recall details
- Recalling firm
- Zimmer Manufacturing B.V.
- Reason for recall
- The firm received a customer complaint establishing that the product (Persona PS Articular Surfaces)information shown on the box differed by sides. One side showed P/N: 42-5114-008-18/ Lot: 62632101 and the other side showed P/N: 42-5114-005-14/ Lot: 62646580.
- Action taken
- Distributors, Sales Representatives, Operation Managers, and Hospital Risk Managers will be provided with an "Urgent Medical Device Recall-Lot Specific" letter.
- Root cause
- Employee error
- Status
- Terminated
- Product code
- JWH
- Quantity affected
- TBD
- Distribution
- Distributed in US (AL, AZ, CA, GA, HI, ID, KS, LA, MA, MN, MO, NY, OH, OK, PA, TX, UT, VA, and WI) and foreign countries (Korea, Japan, Germany, Singapore, Austria, Italy, South Africa, and Spain).
- Date initiated
- 2016-03-17
- Date posted
- 2016-04-06
- Date terminated
- 2017-03-14
- Location
- Mercedita, PR
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 |