Recall Z-2136-2013— Stelkast Co
Class II · Terminated
Class II FDA medical device recall by Stelkast Co, initiated 2013-06-24, terminated 2014-10-08. It names one FDA 510(k) clearance: K021908. Product: 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: 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..
- Recalling firm
- Stelkast Co
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-06-24
- Terminated
- 2014-10-08
- Firm location
- Mcmurray, PA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.