Recall Z-2818-2020 ยท GAD Retractor
Smith & Nephew, Inc.
Single RIKKI Retractor, Catalog #71934609 - Product Usage: is used during surgery to hold soft tissue away from the surgical site.
| Date | Aug 3, 2020 |
| Status | Terminated |
| Reason | The products were improperly heat treated. |
| Root cause | Process control |
| Action | Smith and Nephew issued an Urgent Medical device recall notice. It states the following: 1. Please inspect your inventory and locate any devices from the listed product and batch numbers in 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 name in the table below. 2. If you have no product to return, please put an X in the appropriate location. 3. If you have product to return, pleas |
| Quantity | 111 units |
| Distribution | US states: CA CO CT GA HI IL IN KY MA MD NC NY OK PA SD TN WA WI OUS countries: AE CO JP KR PL ZA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.