Persona, The Personalized Knee System,Tibial Drill, Cemented, 15.7 mm Diameter, Nonsterile This device is indicated for
FDA device recall Z-0545-2013 · posted 2012-12-18 · Terminated
Recall details
- Recalling firm
- Zimmer, Inc.
- Reason for recall
- All lots of the Persona Cemented Tibial Drill, 5 Degree Cemented Stemmed Natural Tibia implants, and associated tools including the Tibial Drill Guide, Broach, and Sizing Plate are being removed and replaced with enhanced products and instruments to reduce risks of tibial perforation which could result in tibial bone fracture due to the stress riser created by a perforation; tibial plate loosening
- Action taken
- Zimmer sent distributors beginning the week of November 14, 2012, E-mail information requesting all equipment be collected in distributors office before shipment back to Zimmer and replacement. A telephone conference discussing the recall and amended surgical technique was held the week of November 14, 2012, and Urgent Recall notices were sent to Distributors describing the devices; risks; updated surgical technique with directions to hand deliver surgeon/risk manager letters to all affected surgeons and risk managers in hospitals receiving the product. The notices included directions to remove all affected product and ensure risk manager letter is provided. The letter stated a Zimmer Inc. employee will conduct onsite reconciliation and asked return of distribution Spreadsheet to CorporateQuality.Postmarket@zimmer.com within 24 hours of receiving notification. Product is to be returned with certificate of sterilization to Zimmer Product Service Department 1777 West Center St. Warsaw, IN 46580 or Zimmer International Logistics, Eschbach Germany for International Accounts. For questions regarding this recall call 574-372-4807.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- JWH
- Quantity affected
- 135
- Distribution
- Worldwide Distribution - USA (nationwide) and internationally to Germany and Europe.
- Date initiated
- 2012-11-14
- Date posted
- 2012-12-18
- Date terminated
- 2014-04-16
- 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 |