FDA Device recall Z-1623-2016
Distal Femoral Replacement (patient specific, custom made orthopedic implant device)
- FDA Device
- Class II
- terminated
- Published 2016-05-18
On 2016-05-18 the FDA classified a Class II recall of Distal Femoral Replacement (patient specific, custom made orthopedic implant device) by Stanmore Implants Worldwide, citing incorrect component used to manufacture distal femoral replacement.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1623-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-04-12 |
| Published | 2016-05-18 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Stanmore Implants Worldwide |
| Distribution | OH |
Product
Distal Femoral Replacement (patient specific, custom made orthopedic implant device). PIN 19960
Reason
Incorrect component used to manufacture distal femoral replacement.
Identifiers
| code_info | Device Identifier: PIN 19960, Lot: 19960 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Other recalls by Stanmore Implants Worldwide
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FDA Device · Class II · 2016-12-28 · Stanmore Implants Worldwide - DF Coated Integral Shaft & Stem 15x30x38
FDA Device · Class II · 2016-12-28 · Stanmore Implants Worldwide - Femoral Shaft L=120mm
FDA Device · Class II · 2016-12-28 · Stanmore Implants Worldwide - Femoral Integral Shaft & Stem 15x27 HA Coated
FDA Device · Class II · 2016-12-28 · Stanmore Implants Worldwide
All Stanmore Implants Worldwide recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1623-2016%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.