Stelkast Co: Medical Device Recall in 2013 - (Recall #: Z-2136-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: June 24, 2013

Date Posted: September 11, 2013

Recall Number: Z-2136-2013

Event ID: 65823

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.

Status: Terminated

Product Quantity: 11

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.

Distribution Pattern:

Nationwide Distribution including TX, VA, OK, and PA

Voluntary or Mandated:

Voluntary: Firm initiated