Smith & Nephew T-F1X0 RCG Drill Pac recall
Smith & Nephew T-F1X0 RCG Drill Pac, 2 mm Drill & (2) Sleeves - Product Usage: indicated for use in surgical arthroscopic rotator cuff repair…
Why was Smith & Nephew T-F1X0 RCG Drill Pac 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
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot Number: 2042492 8/28/20 Expanded Recall- Lot number 2049408
- Product
- Smith & Nephew T-F1X0 RCG Drill Pac, 2 mm Drill & (2) Sleeves - Product Usage: indicated for use in surgical arthroscopic rotator cuff repair…
- Recalling firm
- Smith & Nephew, Inc.
- Quantity
- 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
- Recall date
- August 5, 2020
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)