Recall Z-0489-2007
Synthes · initiated December 5, 2006
Product
LCP Volar Distal Radius Plate Extra Articular 4H HD-RT-Long, LCP Volar Distal Radius Plate 2.4 mm, Catalog number 242.465
Codes / lots: Catalog number 242.465, Lot number 5373486
Reason for recall
Hole is malformed, leading to reduced construct strength.
FDA-determined cause: Other
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.
Details
- Recall number
- Z-0489-2007
- Initiated
- December 5, 2006
- Posted by FDA
- January 11, 2007
- Terminated
- February 13, 2007
- Product code
- HRS – Plate, Fixation, Bone
- 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.
- Recalling firm
- Synthes, West Chester, PA