Reported Aug 5, 2020 · Ongoing

Smith & Nephew T-F1X0 RCG Drill Pac, 2 mm Drill & (2) Sleeves - Product Usage: indicated for use in surgical…

Smith & Nephew, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Smith & Nephew, Inc. · 150 Minuteman Rd · Andover, MA · 01810-1031

Is this the product you have?

    • Smith & Nephew T-F1X0 RCG Drill Pac
    • 2
  • mm Drill & (2) Sleeves - Product Usageindicated for use in surgical arthroscopic rotator cuff repair procedures
  • REF/ Catalog Number014771
Lot codes and dates
  • Lot Number2042492 8/28/20 Expanded Recall- Lot number 2049408
Amount recalled
137 Lot 2042492; 130 Lot 2049408

Where it was sold

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 6:13 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.