—#74834

Product

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.

FDA product code: JWH — Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K051977
Affected lot / code info: 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.

Why it was recalled

Stryker Orthopaedics became aware of a potential anomaly related to the packaging process of referenced lots of X# polyethylene used on Scorpio, Triathlon and Trident inserts.

Root cause (FDA determination)

Process design

Action the firm took

Stryker Orthopaedics issued an "Important Market Withdrawal" notification dated February 17, 2007 via federal express. Consignees were informed of the affected product and asked to retrieve, reconcile and return product via Return Material Authorization to the firm. For further information, contact Stryker Orthopaedics Quality Assurance at 1-201-831-5825.

Recalling firm

Firm: Stryker Howmedica Osteonics Corp.
Address: 325 Corporate Dr, Mahwah, New Jersey 07430

Distribution

Distribution pattern: Worldwide Distribution -- United States and Canada.

Timeline

Recall initiated: 2006-02-17
Posted by FDA: 2010-03-02
Terminated: 2010-03-03
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #74834. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.