Distal Femoral Replacement recall
Distal Femoral Replacement (patient specific, custom made orthopedic implant device). PIN 19960
Why was Distal Femoral Replacement recalled?
Incorrect component used to manufacture distal femoral replacement.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Device Identifier: PIN 19960, Lot: 19960
- Product
- Distal Femoral Replacement (patient specific, custom made orthopedic implant device). PIN 19960
- Recalling firm
- Stanmore Implants Worldwide Ltd.
- Quantity
- 1
- Distribution
- US distribution to OH.
- Recall date
- May 18, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)