Device 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
Z-2702-2020
Product summary
- Event
- Event 85984
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 137 Lot 2042492; 130 Lot 2049408
- Official record key
device-enforcement:Z-2702-2020
Official wording
Reason: 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
Code information: Lot Number: 2042492 8/28/20 Expanded Recall- Lot number 2049408
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
Derived failure modes
-
Unknown
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