Device product
LCP Dia-Meta Volar Distal Radius Plate 15 H Shaft/LT-Sterile; Indicated for fractures, osteotomies, and non-unions of the radius and other small bones.
Z-1949-2016
Product summary
- Event
- Event 74082
- Status
- Terminated
- Classification
- Class II
- Quantity
- 6 units
- Official record key
device-enforcement:Z-1949-2016
Official wording
Reason: Product incorrectly packaged. The labels on the outside of the box and on the LCP Dia-Meta Volar Distal Radius Plate inside the box are correct; however, the preprinted box which contains the LCP-Dia-Meta Volar Distal Radius Plate is incorrect. The box is preprinted for a 4.5 mm LCP Condylar Plate - Distal Femur.
Code information: Lot Number 9890811, Catalog ID 02.110.115S
Distribution pattern: Distributed to one customer: Colorado
Derived failure modes
-
Unknown
Product incorrectly packaged. The labels on the outside of the box and on the LCP Dia-Meta Volar Distal Radius Plate inside the box are correct; however, the preprinted box which contains the LCP-Dia-Meta Volar Distal Radius Plate is incorrect. The box is preprinted for a 4.5 mm LCP Condylar Plate - Distal Femur.