Serrato 9.5mm X 90mm Polyaxial Screw recall
Serrato 9.5mm X 90mm Polyaxial Screw Catalog Number 482619590 Serrato 9.5mm X 100mm Polyaxial Screw Catalog Number 4826195100
Why was Serrato 9.5mm X 90mm Polyaxial Screw recalled?
Discrepant length; Lot B88751 90mm screws were manufactured with a 100mm length instead of the required 90mm length; lot B90243 100mm screws were manufactured with a 90mm length instead of the required 100mm length.
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 # B88751 UDI: (01)07613327351576(11)190125(10)B88751
- Product
- Serrato 9.5mm X 90mm Polyaxial Screw Catalog Number 482619590 Serrato 9.5mm X 100mm Polyaxial Screw Catalog Number 4826195100
- Recalling firm
- Howmedica Osteonics Corp.
- Quantity
- 11
- Distribution
- US Nationwide Distribution - CA, FL, GA, MA, NY, PA, TX
- Recall date
- August 14, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)