SCFE — Class II medical device recall Z-0270-2020
Terminated recall by Pega Medical Inc., reported 2019-11-13, distributed nationwide. There is a potential for the screws to have become loosened during ultrasonic cleaning of the knobs and the sc
| Recall number | Z-0270-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Pega Medical Inc., Laval, N/A, Canada |
| Recall initiated | 2019-10-02 |
| Classified | 2019-11-01 |
| Reported by FDA | 2019-11-13 |
| Terminated | 2020-10-26 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AU, CA, DE, DK, GB, IL, MX, RO, RU |
| Quantity | 31 devices |
| Lot numbers | 160428-03, 160428-04, 160603-05, 160603-06, A182-05, A182-15, A183-06 |
| Model numbers | SCF-KNB265, SCF-KNB273, SCF-KNB365, SCF-KNB373 |
Product
SCFE (slipped capital femoral epiphysis) Knobs for Driver, 6.5mm and 7.3 mm Orthopedic surgical instrument component, for hip surgery
Reason for recall
There is a potential for the screws to have become loosened during ultrasonic cleaning of the knobs and the screws may come out.
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-0270-2020. 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.