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
Reported: August 5, 2020 Initiated: June 24, 2020 #Z-2702-2020
Product Description
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
Details
- Recalling Firm
- Smith & Nephew, Inc.
- Units Affected
- 137 Lot 2042492; 130 Lot 2049408
- 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
- Location
- Andover, MA
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Smith & Nephew, Inc.. Units affected: 137 Lot 2042492; 130 Lot 2049408.
Why was this product 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
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 5, 2020. Severity: Moderate. Recall number: Z-2702-2020.
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