Encina HA Femoral Stem recall: Labeling Error
Encina HA Femoral Stem, Size 11 Coxa Vara Collared, REF 100-30-011, Ti6AI4V Allow with HA Coating, For use with Stinson Orthopedics Inc. Total Hip…
Why was Encina HA Femoral Stem recalled?
The firm has identified that packaging containing components of the hip replacement range are mislabeled. This could result in the product intended to be used for a procedure not included in the packaging resulting in a surgical delay.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA 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 # 7DD49-1
- Product
- Encina HA Femoral Stem, Size 11 Coxa Vara Collared, REF 100-30-011, Ti6AI4V Allow with HA Coating, For use with Stinson Orthopedics Inc. Total Hip…
- Recalling firm
- Signature Orthopaedics Europe Ltd
- Quantity
- 5 components
- Distribution
- US: California
- Recall date
- April 1, 2020
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)