Z-1623-2016Class II

Distal Femoral Replacement (patient specific, custom made orthopedic implant device). PIN 19960

Name: Z-1623-2016 Distal Femoral Replacement (patient specific, custom made orthopedic implant device). PIN 19960
Creator: Stanmore Implants Worldwide Ltd.
Published: 2016-04-12
License: https://open.fda.gov/license/

Stanmore Implants Worldwide, Ltd. / initiated 2016-04-12 / Terminated / root cause: manufacturing process

FDA source

Stanmore Implants Worldwide Ltd. began a recall of Distal Femoral Replacement (patient specific, custom made orthopedic implant device). PIN 19960 on 2016-04-12. FDA classified it as Class II and gives the reason as "Incorrect component used to manufacture distal femoral replacement". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1623-2016
Classification: Class II
Status: Terminated
Initiated: 2016-04-12
Posted: 2016-05-09
Terminated: 2017-01-26
Recalling firm: Stanmore Implants Worldwide, Ltd.
Product: Distal Femoral Replacement (patient specific, custom made orthopedic implant device). PIN 19960
Product code: JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Reason for recall: Incorrect component used to manufacture distal femoral replacement.
Root cause tag: manufacturing process
FDA root cause: Mixed-up of materials/components
Action: A notification was sent to the prescribing physician on 04/12/2016.
Quantity in commerce: 1
Distribution: US distribution to OH.
Product codes and lots: Device Identifier: PIN 19960, Lot: 19960

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1623-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1623-2016	Class II	Terminated	Voluntary: Firm initiated	2016-05-18	2016-05-09

Product code JWH

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)