Recall Z-0956-2013 ยท HRS Plate, Fixation, Bone
Synthes USA HQ, Inc.
Variable Angle Locking Compression Plate/VA-LCP Dorsal Distal Radius Plate, Part Number 02.115.431. Indicated for: Dorsally displaced fractures, Open joint reconstruction, and Corrective osteotomies after distal radius malunion.
| Date | Mar 15, 2013 (initiated Jan 11, 2013) |
| Status | Terminated |
| Reason | It was discovered that one of the VA-LCP Dorsal Distal Radius Plates was incorrectly etched as Part Number 02.115.431 (110 degree) instead of the correct Part Number 02.115.231 (90 degree). |
| Root cause | Labeling mix-ups |
| Action | The firm initiated their recall of this product on January 11, 2013 by sending an Urgent Notice: Medical Device Recall letter to consignees. The letter identified the affected product and the issue. Synthes requested customers to examine their inventory for the affected product, remove them from use, and return them to Synthes. Additionally, customers were to follow the steps provided in the event that they did or did not have any affected product on hand. Questions should be directed to 610-719-5450 or FieldAction@synthes.com. |
| Quantity | 4 |
| Distribution | Distributed in the states of IN, OH, PA, and TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K102694 | 2.4MM VA-LCP DORSAL DISTAL RADIUS PLATES Synthes (Usa), Dec 9, 2010 |