DT Medical -Hintermann Series H3 Poly Inlay recall: Labeling Error
DT Medical -Hintermann Series H3 Poly Inlay, Size 3 5mm Part Number: 300305 components are prostheses for a mobile bearing ankle joint.
Why was DT Medical -Hintermann Series H3 Poly Inlay recalled?
Incorrect package labeling identifying the device
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?
Lot: AAADP
- Product
- DT Medical -Hintermann Series H3 Poly Inlay, Size 3 5mm Part Number: 300305 components are prostheses for a mobile bearing ankle joint.
- Recalling firm
- DT MedTech, LLC
- Quantity
- 54 units
- Distribution
- Australia, Ireland, Korea, Germany
- Recall date
- November 14, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)