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

Recall Z-1535-2023 — LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 13 MM X 55 MM Item Number: 15-2030/12

U.S. FDA — Device Enforcement · United States · 2023-03-21 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1535-2023
Date of alert
2023-03-21
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Linkbio Corp.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
04026575044160
Reported risk: Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the implant caused by suboptimal positioning of the implant or inadequate cementing technique leading to an unsatisfactory surgical result, and in the worst case, intervention or revision earlier than expected
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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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.