Home / Recalls / Stelkast Co / Z-2136-2013

Z-2136-2013 Class II Terminated

Recalled by Stelkast Co — Mcmurray, PA

Recall Details

Product Type
Devices
Report Date
September 11, 2013
Initiation Date
June 24, 2013
Termination Date
October 8, 2014
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
11

Product Description

SC2316, Distal Femoral Augment with Screw Total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis and/or post-traumatic degenerative problems and revision of failed previous reconstructions.

Reason for Recall

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.

Distribution Pattern

Nationwide Distribution including TX, VA, OK, and PA

Code Information

Part number SC2316-3-5 with lot number 22389-111609. Part number SC2316-4-5 with lot number 22587-111609. Part number SC2316-5-5 with lot number 23214-111609.

Other recalls by Stelkast Co

  • Z-0970-2015 Class II — EXp Tibial Insert ; Intended Use of Device(s): The Proven Gen-Flex Total Knee S (December 1, 2014)
  • Z-1066-2013 Class II — Stelkast Cross-over Acetabular Shell and Liner Hip System, Part Numbers SC3458-5 (January 24, 2013)