UKNEE Patella,small 2401-1010 UKNEE Patella,medium 2401-1020 UKNEE Patella,large 2401-1030 UKNEE Patella,X-large 2401-10
FDA device recall Z-1380-2013 · posted 2013-05-24 · Terminated
Recall details
- Recalling firm
- Orthopedic Alliance LLC
- Reason for recall
- The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Orthopedic Alliance because the directions for use and surgical techniques were not being provided to every physician and for every surgery.
- Action taken
- A recall letter dated 3/8/13 was sent to all customers who purchased loaner bins and sterilization trays for implants and instruments from Orthopedic Alliance. The letter informed the customers of the problem identified and the actions to be taken. Customers are instructed to call the office at the number (951) 304-9001 if they are requesting paper copies of any of the literature.
- Root cause
- Labeling design
- Status
- Terminated
- Product code
- JWH
- Quantity affected
- 57 units
- Distribution
- Nationwide Distribution including the states of CA, MD, TX, NV, and WI.
- Date initiated
- 2013-02-20
- Date posted
- 2013-05-24
- Date terminated
- 2014-03-26
- Location
- Murrieta, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| UNITED U2 XPE TOTAL KNEE SYSTEM (K103733) | United Orthopedic Corporation | 2011-08-02 |