EXp Tibial Insert — Class II medical device recall Z-0970-2015
Terminated recall by Stelkast Co, reported 2015-01-21, distributed in CA, GA, IL, IN, KS, MD, NY, PA…. Difficulty locking EXp tibial inserts into tibial trays, caused by a manufacturing condition where a lead in r
| Recall number | Z-0970-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Stelkast Co, Mcmurray, PA, United States |
| Recall initiated | 2014-12-01 |
| Classified | 2015-01-14 |
| Reported by FDA | 2015-01-21 |
| Terminated | 2015-05-06 |
| Distributed | CA, GA, IL, IN, KS, MD, NY, PA, TX, WA |
| Quantity | 553 |
| Lot numbers | 28592-103112, 28593-102412, 28598-103112, 28598-111412, 28599-111412, 28602-110112, 28603-110112, 28607-111912, 28613-110112, 28617-110112, 28618-110112, 28622-112812, 28623-112812, 28624-112812, 31028-120913, 31029-120913, 31031-121013, 31032-121013, 31033-121013, 31034-120913, 31037-121013, 31040-121013, 31042-121013, 31043-120913, 31044-120913, 31243-022414, 31244-022414, 31245-022414, 31249-022514, 31251-022514, 31252-021314, 31255-020414, 31261-020414, 31263-021314, 31264-031114, 31265-031114, 31266-031114, 32081-080714, 32083-080714 |
| Model numbers | SC3425, SC3453 |
Product
EXp Tibial Insert ; Intended Use of Device(s): The Proven Gen-Flex Total Knee System is intended for: a. Total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis, and/or post-traumatic degenerative problems; and b. Revision of failed previous reconstructions where sufficient bone stock and soft tissue integrity are present.
Reason for recall
Difficulty locking EXp tibial inserts into tibial trays, caused by a manufacturing condition where a lead in radius on the anterior locking tab is not present on certain insert lots. The absence of this lead in may prevent or make assembly of the insert and tray difficult.
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-0970-2015. 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.