VKS PE Tibia Insert Ultra-Congruent; Left, Size 2, 12mm; Model Number: 0214612; Plus Orthopedics, San Diego, CA 92121
FDA device recall Z-0361-2008 · posted 2007-12-08 · Terminated
Recall details
- Recalling firm
- Plus Orthopedics USA
- Reason for recall
- Labeling Error: The VKS PE Ultra-congruent insert package, may actually contain a Standard PE insert.
- Action taken
- Consignees were notified by telephone on 11/13/2006 to check their inventory and return any affected units. On 11/28/06 Physician Notifications and Patient Assessment forms were sent to the two physicians who had implanted a total of 4 devices.
- Root cause
- Employee error
- Status
- Terminated
- Product code
- JWH
- Quantity affected
- 10
- Distribution
- Nationwide: USA including states of ID, NY, VA & WI
- Date initiated
- 2006-11-13
- Date posted
- 2007-12-08
- Date terminated
- 2007-12-13
- Location
- San Diego, CA
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| VKS KNEE SYSTEM (K022204) | Plus Orthopedics | 2002-10-18 |