Device product
Smith+Nephew Orthopaedic Division LEGION A/P FEMORAL CUTTING BLOCK, SIZE 6 REF 71434411, QTY: (1) The LEGION AP Femoral Cutting Block is a reusable surgical instrument used to make bone cuts on the distal femur to prepare the bone to receive a LEGION femoral implant.
Z-0200-2019
Product summary
- Event
- Event 81100
- Status
- Terminated
- Classification
- Class II
- Quantity
- 6 units
- Official record key
device-enforcement:Z-0200-2019
Official wording
Reason: One lot of the Legion AP femoral cutting block, size 6, was manufactured with an oversized spring.
Code information: Lot 17LM05396
Distribution pattern: US Distribution to the states of: KS and TN.
Derived failure modes
-
Unknown
One lot of the Legion AP femoral cutting block, size 6, was manufactured with an oversized spring.