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

Recall Z-2702-2020 — Smith & Nephew T-F1X0 RCG Drill Pac, 2 mm Drill & (2) Sleeves - Product Usage: indicated for use in surgical arthroscopic rotator cuff repair procedures. REF/ Catalog Number : 014771

U.S. FDA — Device Enforcement · United States · 2020-06-24 · Class II

AI-assisted, human-edited — this page is drafted with AI from public-source data, then reviewed before publication. How we use AI →
Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2702-2020
Date of alert
2020-06-24
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Smith & Nephew, Inc.
Product category
device
Product type
Devices
Reported risk: The T-Fix sterile package contains only one sleeve instead of two, The device will not perform as intended for the second bone tunnel due to the absence of thesleeve
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.

Related

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.