# FDA recall Z-2702-2020

> **Smith & Nephew, Inc.** · Class II · device recall initiated 2020-06-24.

## 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

## Reason for recall

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

## Distribution

Worldwide distribution - US Nationwide distribution including in the state of CO and the countries of AT, BE, CH, CL, DE, DK, ES, FR, GB, IT.  Expanded 8/28/20 recall: 2nd Field Action: AU, CH, DE, FR, GB, IT, NL, PL, PT,  & ZA

## Key facts

- **Recall number:** Z-2702-2020
- **Recalling firm:** Smith & Nephew, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2020-06-24
- **Report date:** 2020-08-05

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Andover, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2702-2020

## Citation

> AI Analytics. FDA recall Z-2702-2020. Retrieved 2026-05-26 from https://api.ai-analytics.org/recall/Z-2702-2020. Source: US FDA. Licensed CC0.

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