Femoral Integral Shaft & Stem 15x27 HA Coated — Class II medical device recall Z-0823-2017
Terminated recall by Stanmore Implants Worldwide Ltd., reported 2016-12-28, distributed nationwide. The recalling firm has received 5 customer inquiries reporting that at least one pouch of the double pouch pac
| Recall number | Z-0823-2017 |
|---|---|
| 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 | 2016-12-07 |
| Classified | 2016-12-19 |
| Reported by FDA | 2016-12-28 |
| Terminated | 2017-07-17 |
| Distributed | Nationwide (US) |
| Quantity | 15 units |
Product
Femoral Integral Shaft & Stem 15x27 HA Coated; Femoral Integral Shaft & Stem 15x30 HA Coated; Femoral Integral Shaft & Stem 30x27 HA Coated; Femoral Integral Shaft & Stem 30x30 HA Coated The product is a component is a systems that is intended for the replacement if diseased or deficient bone around the knee joint, distal femur, proximal femur or total femur bone
Reason for recall
The recalling firm has received 5 customer inquiries reporting that at least one pouch of the double pouch packaging configuration has been punctured by the tip of the device's stem.
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-0823-2017. 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.