Recall Z-0143-2022 ยท HWC Screw, Fixation, Bone
Smith & Nephew, Inc.
6.5MMX165MM CANNULATED SCREW
| Date | Sep 20, 2021 |
| Status | Terminated |
| Reason | The product label incorrectly indicated that the screws are fully threaded, but the screws contained in the package were partially threaded. |
| Root cause | Process control |
| Action | Smith & Nephew issued a customer letter via email dated September 20, 2021. Consignees are asked to inspect inventory and locate any devices from the listed product and batch numbers enclosed with the Urgent Medical Device Recall Notice, and quarantine them immediately. Consignees must complete the enclosed response form, sign and send to FieldActions@smith-nephew.com. Response form shall be completed even if there is no impacted product on hand. |
| Quantity | 5 units |
| Distribution | Worldwide distribution - US Nationwide distribution in the states of OK, TN and the country of Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K060736 | SMITH & NEPHEW 6.5MM AND 8.0MM CANNULATED SCREWS Smith & Nephew, Inc., Apr 18, 2006 |