Recall Z-0265-2022 ยท HRS Plate, Fixation, Bone
Smith & Nephew, Inc.
Smith and Nephew EVOS Self-Tapping Locking Screw SST: (1)REF 72413575, 3.5MM x 75MM, and (2) REF 72413570, 3.5MM X 70MM. Sterile.
| Date | Oct 25, 2021 |
| Status | Open, Classified |
| Reason | The labels on the packages of screws were switched. |
| Root cause | Error in labeling |
| Action | The recalling firm issued letters dated 10/25/2021 on the same day via email and FedEx overnight. The letter explained the issue and the potential risk of use of the product. Required actions were listed on the enclosed response form. The actions included inspecting their inventory and quarantining the affected product immediately and returning it. Distributors or sales representatives were to notify their customers of the field action and ensure the required actions are complete. |
| Quantity | 224 units |
| Distribution | Distribution was made to AL, AZ, CA, CO, CT, FL, GA, IL, IN, KY, LA, MA, ME, MI, MN, MO, NC, NJ, NY, OH, OR, PA, TN, TX, and WA. There was no direct government distribution. There was no military distribution. Foreign distribution was made to Australia, Canada, China, Dubai/MENA, Germany, Italy, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K162078 | EVOS Small Fragment Plating System Smith & Nephew, Inc., Nov 18, 2016 |