Recall Z-1757-2020 ยท MBI Fastener, Fixation, Nondegradable, Soft Tissue
Smith & Nephew, Inc.
Smith & Nephew FOOTPRINT Ultra PK Suture Anchor, 5.5mm Part Number: 72202902
| Date | Mar 17, 2020 |
| Status | Open, Classified |
| Reason | Space between the device and the packaging permits excessive movement which could potentially lead to the displacement of the anchor s tip protector allowing the tip of the anchor to create a sterile breach. |
| Root cause | Package design/selection |
| Action | Smith & Nephew issued Urgent Medical Device Recall letter to International customers on March 17, 2020 and FedEx letters to US customers on March 18, 2020. Letter states reason for recall, health risk and action to take: Required Actions: 1. Please inspect your inventory and locate any devices from the listed product and batch numbers on the first page of this Urgent Medical Device Recall Notice, and quarantine them immediately.a. If you are a distributor, you must notify your customers of the field action and ensure that these actions are carried out. 2. If you have no product to return, plea |
| Quantity | 125,196 (Total) |
| Distribution | Nationwide Foreign: AE AL AR AT AU BE BM BR CA CH CL CN CO CR CZ DE DK EC EE ES FI FR GB IE IL IN IT KR LT LV MT MX NO PA PE PL PR PT QA RU SE SG TH TR XK ZA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K093897 | SMITH & NEPHEW FOOTPRINT ULTRA PK SUTURE ANCHOR Smith & Nephew Inc., Endoscopy Div., Mar 4, 2010 |