1757-1: Compressor/Distractor Instrument (aka Plate Distractor Forceps), and product literature. Devices are manufacture
FDA device recall Z-0808-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- Spinal Concepts, Inc
- Reason for recall
- Design has insufficient articulating distance between the two component plates to prevent disassociation in vivo.
- Action taken
- The firm initiated the recall via telephone on 03/01/2004 to all distributors followed up by recall letter on 03/05/2004.
- Root cause
- Other
- Status
- Terminated
- Product code
- KWQ
- Quantity affected
- 25 (1757-1)
- Distribution
- Nationwide
- Date initiated
- 2004-03-01
- Date posted
- 2004-07-20
- Date terminated
- 2007-04-13
- Location
- Austin, TX
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SPINAL CONCEPTS, INC. ANT-CER DYNAMIC ANTERIOR CERVICAL PLATE SYSTEM (K024326) | Spinal Concepts, Inc. | 2003-01-23 |