Food, drugs, devices › Stanmore Implants Worldwide Ltd.
Device recall: Distal Femoral Replacement (patient specific, custom made orthopedic implant device). PIN 19960
Stanmore Implants Worldwide Ltd. (Borehamwood, N/A) initiated this device recall on 12 Apr 2016; FDA lists 1 product record under event 73856, classified Class II.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 91% of the 1,232 device enforcement events initiated in 2016 carry the same class.
Status: Terminated, terminated 26 Jan 2017. Initiation: voluntary: firm initiated. Stanmore Implants Worldwide Ltd. has 4 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Stanmore Implants Worldwide Ltd., Borehamwood, N/A, United Kingdom.
Reason for recall
"Incorrect component used to manufacture distal femoral replacement."
Distribution
"US distribution to OH."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1623-2016 | Distal Femoral Replacement (patient specific, custom made orthopedic implant device). PIN 19960 | 1 | Class II | Terminated | 18 May 2016 |
Context
Other enforcement events for Stanmore Implants Worldwide Ltd.
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 4 Jul 2017 | JTS External Drive Unit JTS Distal Femoral Extendible Implant Femur is intended for the replacement of diseased or defic | Device | Class II | 1 |
| 7 Dec 2016 | Tibial Component Fixed Hinge Small Long; Tibial Component Fixed Hinge Small Short The product is a component is a system | Device | Class II | 5 |
| 31 May 2016 | METS SMILES Total Knee Replacement | Device | Class II | 1 |
All 4 events for Stanmore Implants Worldwide Ltd.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Incorrect component used to manufacture distal femoral replacement."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "US distribution to OH."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 26 Jan 2017. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.