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FDA device recall Z-0198-2015 · posted 2014-11-08 · Terminated
Recall details
- Recalling firm
- Zimmer, Inc.
- Reason for recall
- Cleaning process validation failure.
- Action taken
- Zimmer sent an Urgent Medical Device Recall letter dated October 9, 2014 to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to: 1. Review the notification and ensure affected personnel are aware of the contents. 2. Assist your Zimmer sales representative with the quarantine of any affected product. 3. Your Zimmer sales representative will remove the recalled product from your facility. 4. If after reviewing this notification you have further questions or concerns please call the customer call center at 1-800-348-2759. Hours of operation are Monday through Friday, 8 a.m. through 8 p.m. EST.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- JWH
- Quantity affected
- 138 units
- Distribution
- US Nationwide Distribution and countries of Austria ,Belgium, Switzerland, Germany, France, United Kingdom, Italy and South Africa.
- Date initiated
- 2014-10-09
- Date posted
- 2014-11-08
- Date terminated
- 2015-06-24
- Location
- Warsaw, IN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ZIMMER PERSONA KNEE SYSTEM (K113369) | Zimmer, Inc. | 2012-03-27 |