Device product
Orthopedic Salvage System (OSS) 9cm prosthesis, knee, femorotibial, constrained, cemented, metal/polymer Knee System Tibial Bodies
Z-1114-2017
Product summary
- Event
- Event 76082
- Status
- Terminated
- Classification
- Class II
- Quantity
- 16
- Official record key
device-enforcement:Z-1114-2017
Official wording
Reason: labeling for specific lots of the Standard OSS Modular Proximal Tibia incorrectly identifies the components as AVL Modular Proximal Tibia. The mislabeling could have the potential risks: A delay in surgery less than 30 minutes. Patient undergoes a revision with increased risk of infection.
Code information: Part # Lot # UDI CP113462 646200 (01) 0 0880304 51008 1 (17) 250928 (10) 646200 CP113462 690040 (01) 0 0880304 51008 1 (17) 260714 (10) 690040 CP113462 003620 (01) 0 0880304 51008 1 (17) 260324 (10) 003620 CP113462 498380 (01) 0 0880304 51008 1 (17) 250929 (10) 498380 CP113462 690050 (01) 0 0880304 51008 1 (17) 260622 (10) 690050 CP113462 539760 (01) 0 0880304 51008 1 (17) 251007 (10) 539760 CP113462 409190 (01) 0 0880304 51008 1 (17) 260417 (10) 409190 CP113462 799300 (01) 0 0880304 51008 1 (17) 260802 (10) 799300 CP113462 460990 (01) 0 0880304 51008 1 (17) 260416 (10) 460990
Distribution pattern: WI NJ CA MD WA LA MA TX
Derived failure modes
-
Labeling or packaging
mislabeling