FDA Medical Device Recalls (openFDA)
Stanmore Implants Worldwide Ltd.: Distal Femoral Replacement (patient specific, custom made orthopedic implant device). PIN 19960
- Recall number
- Z-1623-2016
- Recalling firm
- Stanmore Implants Worldwide Ltd.
- Product
- Distal Femoral Replacement (patient specific, custom made orthopedic implant device). PIN 19960
- Status
- Terminated
- Initiated
- 2016-04-12
- Posted
- 2016-05-09
- Terminated
- 2017-01-26
- Reason
- Incorrect component used to manufacture distal femoral replacement.
- Root cause
- Mixed-up of materials/components
- Action
- A notification was sent to the prescribing physician on 04/12/2016.
- Quantity
- 1
- Distribution
- US distribution to OH.
- Lot, serial or model codes
- Device Identifier: PIN 19960, Lot: 19960
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- JWH
- Firm FEI
- 3004105610
- Firm city
- Borehamwood
- Firm state
- Centennial
- Firm country
- United Kingdom
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28