The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-2702-2020·Announced 2020-08-05

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.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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.
Category
Medical Device — Surgical Instruments
Hazard

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

Distributed nationwide across the United States.

The notice also names 2 states specifically:

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