Depuy TK2 Compression Hip Screw trauma plate, Standard Barrel,135 Degree, 4H-92.6mm, sterile; REF 8315-35-004, DePuy Ort
FDA device recall Z-0434-2008 · posted 2008-01-24 · Terminated
Recall details
- Recalling firm
- Depuy Orthopaedics, Inc.
- Reason for recall
- Mis-etched/labeled as to barrel length: the lot with the short barrel was etched and labeled as a standard barrel and the lot with the standard barrel was etched and labeled as a short barrel.
- Action taken
- Consignees were notified via Urgent Information, Recall Notice(letter) dated 10/30/07 to determine whether they have product on hand and to contact their sales representative to return the product. Dear Doctor letters will be issued to implanting physicians as they are identified.
- Root cause
- Process control
- Status
- Terminated
- Product code
- KTT
- Quantity affected
- 9
- Distribution
- Nationwide including the states of Florida, Massachusetts, Ohio, Pennsylvania, South Carolina, Tennessee and Virginia.
- Date initiated
- 2007-10-30
- Date posted
- 2008-01-24
- Date terminated
- 2008-04-21
- 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 |
|---|---|---|
| DEPUY AE TK2 HIP SCREW SYSTEM (K972629) | Depuy, Inc. | 1997-10-09 |