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

Recall Z-1674-2023 — LINK SymphoKnee System L-Shaped Femoral Augment, Medial-Right/Lateral-Left, Sz 5-6 Tilastan, cemented. Intended for primary and revision total knee replacement. Item Number: 880-325/13

U.S. FDA — Device Enforcement · United States · 2023-04-25 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1674-2023
Date of alert
2023-04-25
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Linkbio Corp.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
04026575258123
Reported risk: Contains the incorrect implant in the packaging. The packaging incorrectly contains the opposite side of the implant (Lateral-Right/Medial-Left instead of Medial-Right/Lateral-Left).
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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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.