FDA Device recall Z-2136-2013
SC2316, Distal Femoral Augment with Screw Total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis and/or post-tra…
- FDA Device
- Class II
- terminated
- Published 2013-09-11
On 2013-09-11 the FDA classified a Class II recall of SC2316, Distal Femoral Augment with Screw Total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis and/or post-tra… by Stelkast, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2136-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-06-24 |
| Published | 2013-09-11 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Stelkast |
| Distribution | US |
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.
Identifiers
| code_info | 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. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2136-2013%22
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