SC2316 — Class II medical device recall Z-2136-2013
Terminated recall by Stelkast Co, reported 2013-09-11, distributed nationwide. The firm became aware of an incident relating to a breach of sterility in the sterility barrier packaging of S
| Recall number | Z-2136-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Stelkast Co, Mcmurray, PA, United States |
| Recall initiated | 2013-06-24 |
| Classified | 2013-09-03 |
| Reported by FDA | 2013-09-11 |
| Terminated | 2014-10-08 |
| Distributed | Nationwide (US) |
| Quantity | 11 |
| Reason classes | sterility |
| Lot numbers | 22389-111609, 22587-111609, 23214-111609 |
| Model numbers | SC2316-3-5, SC2316-4-5, SC2316-5-5 |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2136-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.