LCP Volar Distal Radius Plate Extra Articular 4H HD-RT-Long, LCP Volar Distal Radius Plate 2.4 mm, Catalog number 242.46
FDA device recall Z-0489-2007 · posted 2007-01-11 · Terminated
Recall details
- Recalling firm
- Synthes
- Reason for recall
- Hole is malformed, leading to reduced construct strength.
- Action taken
- All Sales Consultants were notified of the recall via teleconference on 12/5/06. The telephone script, part number and affected lot were communicated to the consultants during the teleconference. They were instructed to retrieve the affected product from the field.
- Root cause
- Other
- Status
- Terminated
- Product code
- HRS
- Quantity affected
- 11 units
- Distribution
- The products were shipped to medical facilities in NJ, TN, LA, and KS. The products were also shipped to sales reps in PA, SC, and CA. The product was also shipped to Canada.
- Date initiated
- 2006-12-05
- Date posted
- 2007-01-11
- Date terminated
- 2007-02-13
- Location
- West Chester, PA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SYNTHES LOCKING DISTAL RADIUS PLATING SYSTEM (K012114) | Synthes (Usa) | 2001-09-28 |