Z-2702-2020 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- August 5, 2020
- Initiation Date
- June 24, 2020
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 137 Lot 2042492; 130 Lot 2049408
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
Distribution Pattern
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
Code Information
Lot Number: 2042492 8/28/20 Expanded Recall- Lot number 2049408