Slipped Capital Femoral Epiphysis System Product Usage: Intended for… — Class II medical device recall Z-0408-2014
Terminated recall by Synthes USA HQ, Inc., reported 2013-12-04, distributed nationwide. There is a possibility for the Guide Wires of the Slipped Capital Femoral Epiphysis System to stick in the can
| Recall number | Z-0408-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Synthes USA HQ, Inc., West Chester, PA, United States |
| Recall initiated | 2013-07-31 |
| Classified | 2013-11-26 |
| Reported by FDA | 2013-12-04 |
| Terminated | 2015-06-01 |
| Distributed | Nationwide (US) |
| Quantity | 166 |
| Reason classes | device malfunction |
| Lot numbers | 03.207.001, 03.207.008, PE00376, PE00377, PE00439, PE00440, PE00504, PE00513, PE01329, PE01391, PE01412, PE01475, PE01691 |
| Model numbers | 03.207.001, 03.207.008, PE00376, PE00377, PE00439, PE00440, PE00504, PE00513, PE01329, PE01391, PE01412, PE01475, PE01691 |
Product
Slipped Capital Femoral Epiphysis System Product Usage: Intended for fracture fixation of large bones and large bone fragments and for slipped capital femoral epiphysis, pediatric femoral neck fractures, intercondylar femur fractures and sacroiliac joint disruptions.
Reason for recall
There is a possibility for the Guide Wires of the Slipped Capital Femoral Epiphysis System to stick in the cannulation of the drill bit and the drill bits to break during surgery.
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-0408-2014. 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.