Serrato 9.5mm X 90mm Polyaxial Screw Catalog Number 482619590 Serrato 9.5mm X 100mm Polyaxial Screw Catalog Number 4826195100
Reported: August 14, 2019 Initiated: June 18, 2019 #Z-2160-2019
Product Description
Serrato 9.5mm X 90mm Polyaxial Screw Catalog Number 482619590 Serrato 9.5mm X 100mm Polyaxial Screw Catalog Number 4826195100
Reason for Recall
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.
Details
- Recalling Firm
- Howmedica Osteonics Corp.
- Units Affected
- 11
- Distribution
- US Nationwide Distribution - CA, FL, GA, MA, NY, PA, TX
- Location
- Allendale, NJ
Frequently Asked Questions
What product was recalled? ▼
Serrato 9.5mm X 90mm Polyaxial Screw Catalog Number 482619590 Serrato 9.5mm X 100mm Polyaxial Screw Catalog Number 4826195100. Recalled by Howmedica Osteonics Corp.. Units affected: 11.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 14, 2019. Severity: Moderate. Recall number: Z-2160-2019.
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