Stelkast Company
Country not established
- Devices
- 44
- FDA recalls
- 13
At a glance
Market reach
- United States
- FDA recalls
What Stelkast Company makes
Stelkast Company manufactures orthopedic implants for hip and knee replacements, including press-fit and cemented femoral components, modular tibial trays, bipolar systems, and ceramic femoral heads. Their portfolio includes revision systems, cobalt-chrome femoral heads, polyethylene liners, and endoprosthesis femoral heads designed for primary and complex joint arthroplasty procedures.
The company’s devices are regulated under FDA pathways, with Class II and Class III classifications. Products are listed via 510(k) and PMA submissions, reflecting their authorization status in the US market.
Catalogue
Search and filter all 44 devicesFDA recalls
FDA recall records list 13 recalls initiated by Stelkast Company, the earliest on 2004-09-24 and the most recent on 2014-12-01. By recorded status: 13 terminated. The reasons filed fall into these groups: labeling or instructions for use, sterility or contamination, packaging, mechanical integrity and manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2014
- 1 Dec 2014 Z-0970-2015 Class II Terminated 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.
2013
- 24 Jun 2013 Z-2136-2013 Class II Terminated 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.
- 24 Jan 2013 Z-1066-2013 Class II Terminated 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.
2009
- 5 May 2009 Z-0371-2010 Unclassified (pre-2012) Terminated incorrect size markings on component
2008
- 31 Oct 2008 Z-1073-2009 Unclassified (pre-2012) Terminated A possible breach of the sterile barrier packaging (Tyvek pouch).
- 7 Oct 2008 Z-0664-2009 Unclassified (pre-2012) Terminated Sterility may be compromised due to breach in packaging.
- 3 Sep 2008 Z-0308-2009 Unclassified (pre-2012) Terminated Five (5) Three Peg Patella SC1591-29 were packaged in containers labeled for SC1591-38 sharing the same lot number.
2007
- 5 Oct 2007 Z-0479-2008 Unclassified (pre-2012) Terminated The screws may fracture
- 5 Oct 2007 Z-0480-2008 Unclassified (pre-2012) Terminated The screws may fracture
- 5 Oct 2007 Z-0481-2008 Unclassified (pre-2012) Terminated The screws may fracture
Show all 13 recalls
2007
- 5 Oct 2007 Z-0482-2008 Unclassified (pre-2012) Terminated The screws may fracture
- 5 Oct 2007 Z-0483-2008 Unclassified (pre-2012) Terminated The screws may fracture
2004
- 24 Sep 2004 Z-0496-05 Unclassified (pre-2012) Terminated Sterility may be compromised. The inner pouch of the implant packaging was sticking out beyond the seal of the outer pouch
Frequently asked questions
How many devices does Stelkast Company have in the registry?
The registry currently lists 44 devices for Stelkast Company. Devices recorded under merged duplicate company entries are counted once.
Which registries list Stelkast Company's devices?
Among its 44 most recently registered devices, Stelkast Company has devices listed in FDA 510(k) (43 devices) and FDA PMA (1 device). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Stelkast Company's devices fall under?
Among its 44 most recently registered devices, the classes recorded for Stelkast Company's devices are Class II and Class III. Each device page shows its own class and authorisation.
Are there FDA recall records for Stelkast Company?
FDA recall records list 13 recalls initiated by Stelkast Company, the most recent initiated on 1 Dec 2014. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Stelkast Company in the registry?
The most recently registered devices listed for Stelkast Company include GENFlex2 Total Knee System - Ultra-Congruent CR Tibial Insert, PROTRACT PRESS FIT HIP STEM, PROFORM CEMENTED FEMORAL COMPONENT and DUAL TAPER WEDGE PRESSED FIT FEMORAL COMPONENT.