Distal Femoral Replacement (patient specific, custom made orthopedic implant device). PIN 19960
FDA device recall Z-1623-2016 · posted 2016-05-09 · Terminated
Recall details
- Recalling firm
- Stanmore Implants Worldwide Ltd.
- Reason for recall
- Incorrect component used to manufacture distal femoral replacement.
- Action taken
- A notification was sent to the prescribing physician on 04/12/2016.
- Root cause
- Mixed-up of materials/components
- Status
- Terminated
- Product code
- JWH
- Quantity affected
- 1
- Distribution
- US distribution to OH.
- Date initiated
- 2016-04-12
- Date posted
- 2016-05-09
- Date terminated
- 2017-01-26
- Location
- Borehamwood, Centennial, United Kingdom
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