Stelkast Recalls
3 recalls on record · April 17, 2013 to January 21, 2015 · Medical Devices
Recalls by year
13
15
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
January 21, 2015Medical DevicesFDA
Stelkast Co recalls EXp Tibial Insert ; Intended Use of Device(s): The Proven Gen-Flex Total Knee System is intended for: a. Total knee rep
Hazard: Difficulty locking EXp tibial inserts into tibial trays, caused by a manufacturing condition where a lead in radius on the anterior locking tab is not present on certain insert lots. The absence of this lead in may prevent or make assembly of the insert and tray difficult.
September 11, 2013Medical DevicesFDA
Stelkast Co recalls SC2316, Distal Femoral Augment with Screw Total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid art
Hazard: The firm became aware of an incident relating to a breach of sterility in the sterility barrier packaging of SC2316, Distal Femoral Augment with Screw.
April 17, 2013Medical DevicesFDA
Stelkast Co recalls Stelkast Cross-over Acetabular Shell and Liner Hip System, Part Numbers SC3458-52, SC3474-52, SC3459-52, and SC3460-52.
Hazard: Firm was made aware of incidents relating to the difficulty of properly engaging and securing the Cross-Over 36mm liner into the Cross-Over shell.