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

Recall Z-1148-2020 — Stryker, Omega 4.75 mm,. PEEK Knotless Anchor System, Single, REF 3910-500-471, UDI 07613327464818, Sterile R, RX Only CE 0197

U.S. FDA — Device Enforcement · United States · 2019-07-19 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1148-2020
Date of alert
2019-07-19
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Stryker Corporation
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
07613327464818
Reported risk: Complaints have been received regarding difficulty in removing the driver from the screw. High driver removal forces can lead to the screw pulling out still attached to the driver. This could result in an additional anchor insertion site in the bone being used.
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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