Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-2160-2019 — Serrato 9.5mm X 90mm Polyaxial Screw Catalog Number 482619590 Serrato 9.5mm X 100mm Polyaxial Screw Catalog Number 4826195100

U.S. FDA — Device Enforcement · United States · 2019-06-18 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2160-2019
Date of alert
2019-06-18
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Howmedica Osteonics Corp.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
07613327351576
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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