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 Pac2
- 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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