Distal Femoral Replacement — Class II medical device recall Z-1623-2016
Terminated recall by Stanmore Implants Worldwide Ltd., reported 2016-05-18. Incorrect component used to manufacture distal femoral replacement.
| Recall number | Z-1623-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Stanmore Implants Worldwide Ltd., Borehamwood, N/A, United Kingdom |
| Recall initiated | 2016-04-12 |
| Classified | 2016-05-09 |
| Reported by FDA | 2016-05-18 |
| Terminated | 2017-01-26 |
| Quantity | 1 |
| Lot numbers | 19960 |
Product
Distal Femoral Replacement (patient specific, custom made orthopedic implant device). PIN 19960
Reason for recall
Incorrect component used to manufacture distal femoral replacement.
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-1623-2016. 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.