Recall Z-2702-2020 ยท HRX Arthroscope
Smith & Nephew, Inc.
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
| Date | Jul 24, 2020 (initiated Jun 24, 2020) |
| Status | Open, Classified |
| 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 |
| Root cause | Process design |
| Action | Smith & Nephew issued Urgent Medical Device Recall Notice R-2020-12 dated June 24, 2020 via email and FedEx. to distributors, sales reps, hospitals or surgeons. Letter states reason for recall, health risk and action to take: Please inspect your inventory and locate any devices from the listed product and batch numbers enclosed with this Urgent Medical Device Recall Notice, and quarantine them immediately. a. If you are a sales rep or distributor, you must notify your customers of the field action and ensure that the required actions are complete. b. Include the customers account number and |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K925573 | ACUFEX T-BAR Acufex Microsurgical, Inc., May 5, 1993 |