Medical device recalls Moderate risk

Howmedica Osteonics Corp. recalls Serrato 9.5mm X 90mm Polyaxial Screw Catalog Number 482619590 Serrato 9.5mm X 100mm Polyaxial Screw Catalog Number 4826…

Recall date
June 18, 2019
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2160-2019
FDA classification
Class II
Brand / firm
Howmedica Osteonics Corp.
Sold / distributed
US Nationwide Distribution - CA, FL, GA, MA, NY, PA, TX

Why it was 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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Serrato 9.5mm X 90mm Polyaxial Screw Catalog Number 482619590 Serrato 9.5mm X 100mm Polyaxial Screw Catalog Number 4826195100

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