Stelkast Co Proven Cemented Semi-Constrained Total Knee. Part number SC1591. The size is 38 and the thickness is 10 mm. The Proven Knee System is a single use device intended for cemented reconstruction of the femoral and/or tibial portion of severely disabled and/or painful knee joints resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis with or without varus, valgus or flexion deformities, and revision surgery provided that there is radiographic evidence of sufficient sound bone to se Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Proven Cemented Semi-Constrained Total Knee. Part number SC1591. The size is 38 and the thickness is 10 mm. The Proven Knee System is a single use device intended for cemented reconstruction of the femoral and/or tibial portion of severely disabled and/or painful knee joints resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis with or without varus, valgus or flexion deformities, and revision surgery provided that there is radiographic evidence of sufficient sound bone to se
Brand
Stelkast Co
Lot Codes / Batch Numbers
Part number SC1591-38. Lot number 19906-052008
Products Sold
Part number SC1591-38. Lot number 19906-052008
Stelkast Co is recalling Proven Cemented Semi-Constrained Total Knee. Part number SC1591. The size is 38 and the thickness is due to Five (5) Three Peg Patella SC1591-29 were packaged in containers labeled for SC1591-38 sharing the same lot number.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Five (5) Three Peg Patella SC1591-29 were packaged in containers labeled for SC1591-38 sharing the same lot number.
Recommended Action
Per FDA guidance
On 9/4/08, the recalling firm telephoned their customers to inform them of the problem and asked them to immediately recover all SC1591-38 with lot number 19906-052008. Once the product is in their possession, customers should contact Stelkast Customer Service for a Return Authorization (RA) Number prior to shipment to Stelkast.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026