Smith & Nephew T-F1X0 RCG Drill Pac Recalled for Missing Sleeve
Smith & Nephew is recalling T-F1X0 RCG Drill Pacs because some sterile packages contain only one sleeve instead of two, preventing the device from performing as intended for the second bone tunnel.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard is a functional defect (missing component) that prevents the device from performing as intended, but the source text does not report any injuries, illnesses, or deaths, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Smith & Nephew, Inc. is recalling the T-F1X0 RCG Drill Pac, 2 mm Drill & (2) Sleeves (Catalog Number 014771). The product is indicated for use in surgical arthroscopic rotator cuff repair procedures. The recall involves 137 units from Lot 2042492 and 130 units from Lot 2049408.
The recall was initiated because the T-Fix sterile package contains only one sleeve instead of the required two. Due to the absence of the second sleeve, the device will not perform as intended for the second bone tunnel.
The affected products were distributed worldwide, including US nationwide distribution and in the countries of AT, BE, CH, CL, DE, DK, ES, FR, GB, and IT. An expanded recall on August 28, 2020, included distribution in AU, CH, DE, FR, GB, IT, NL, PL, PT, and ZA. Healthcare providers should stop using the affected lots and contact Smith & Nephew for instructions on return or replacement.
The recalled product
- Product
- 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
- Manufacturer
- Smith & Nephew, Inc.
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot Number: 2042492 8/28/20 Expanded Recall- Lot number 2049408
Distribution
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