Smith & Nephew FOOTPRINT Ultra PK Suture Anchor, 5.5mm Part Number: 72202902

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.

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, please put an X in the appropriate location 3. If you have product to return, please list the item, batches and quantities that you are returning in the appropriate boxes below. 4. Complete the remainder of the form, sign and send to [email protected] or fax to +1-901-566-7975. Please Note even if you have no product to return, this form must be completed, signed and returned. 5. Once the form is received by Smith & Nephew, you will be sent a Return Authorization (RA) number. If you have any questions or concerns regarding this recall please contact [email protected].