Recall Z-0489-2007 ยท HRS Plate, Fixation, Bone
Synthes
LCP Volar Distal Radius Plate Extra Articular 4H HD-RT-Long, LCP Volar Distal Radius Plate 2.4 mm, Catalog number 242.465
| Date | Jan 11, 2007 (initiated Dec 5, 2006) |
| Status | Terminated |
| Reason | Hole is malformed, leading to reduced construct strength. |
| Root cause | Other |
| Action | 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. |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K012114 | SYNTHES LOCKING DISTAL RADIUS PLATING SYSTEM Synthes (Usa), Sep 28, 2001 |