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 seat the prosthesis.
FDA Recall Z-0308-2009 · Posted 2008-11-25
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Recalling FirmStelkast Co
Recall StatusTerminated
Product CodeJWH
Date Initiated2008-09-03
Date Terminated2008-12-04
Product Quantity5 units
Reason for Recall
Five (5) Three Peg Patella SC1591-29 were packaged in containers labeled for SC1591-38 sharing the same lot number.
Firm Action
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.
Root Cause
Employee error
Distribution Pattern
Nationwide Distribution --- including states of IA and WV.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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