Devices

Device Recall Scorpio X3 UHMPWE Tibial Inserts and Scorpio X3 UHMWPE Patellar Components

Model / Serial
Lot Numbers: 35458101; 36121101; 36121401; 36209601; 36209701; 35904301; 35904501; 35904701; 36294401; 36297801; 36605701; 36297902; 36605801; 35904901; 36298101; 35905001; 36298201; 35905101; 35905301; 36295101; 35905501; 36298801; 36298902; 36299301; 35906001; 36007001; 36301001; 36007101; 36301301; 36862701; 36011001; 36606201; 36606401; 36011801; 36301501; 36012201; 36012301; 36301901; 36012901; 36302001; 36013001; 36013401; 36302101; 36302301; 36014501; 36014701A 36014801; V145; V146; V148; V161; V162; V163; V165; V166; V024C and V026C.
Product Classification
Orthopedic Devices
Device Class
2
Implanted device?
Yes
Distribution
Worldwide Distribution -- United States and Canada.
Product Description
Scorpio X3 UHMPWE Tibial Inserts and Scorpio X3 UHMWPE Patellar Components, multiple sizes, Stryker Orthopaedics, Mahwah, NJ. || Intended to be used with cemented or cementless components in primary or revision total knee arthroplasty.
Manufacturer
Stryker Howmedica Osteonics Corp.
1 Event
- Recall of Device Recall Scorpio X3 UHMPWE Tibial Inserts and Scorpio X3 UHMWPE Patellar Components

Manufacturer

Stryker Howmedica Osteonics Corp.

Manufacturer Address
Stryker Howmedica Osteonics Corp., 325 Corporate Dr, Mahwah NJ 07430
Manufacturer Parent Company (2017)
Stryker
Source
USFDA

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