Class 2 Device Recall HEALICOIL RG SA 5.5MM W/3 UBBL CB BL BK Absorbable Suture anchor

• Date Initiated by Firm: September 09, 2020
• Create Date: October 21, 2020
• Recall Status: Open, Classified
• Recall Number: Z-0171-2021
• Recall Event ID: 86462
• 510(K)Number: K151105
• Product Classification: Fastener, fixation, biodegradable, soft tissue - Product Code MAI
• Product: HEALICOIL RG SA 5.5MM W/3 UB-BL CB BL BK- Absorbable Suture anchor; Product Number: 72203707
• Code Information: Batch Numbers: 2011426 2011425 2011427 2014000 2014001 2016191 2016231 2016190 2017773 2017813 2017845 2018741 2018798 2018852 2019891 2019890 2020050 2021455 2021497 2021545 2023183 2023182 2023271 2024718 2024720 2024722 2027219 2027436 2027406 2029150 2029352 2029399 2030953 2030954 2031092 2031093 2031157 2031158 2032824 2032825 2033399 2033398 2033538 2033537 2035454 2035455 2035540 2035541 2036290 2036696 2037152 2038469 2038804 2038805 2039452 2039453 2039454 2039455 2041421 2041071 2041072 2041073 2041074 2042598 2042779 2042778 2045871 2045872 2045873 2045874 2045875 2044895 2046745 2048396 2048397 2048398 2048401 2048402 2048403 2049922 2049923 2049917 2049918 2048399 2049919 2049920 2049921 2051017 2051018 2051019 2052178 2052181 2052179 2052180 2052182 2052183 2053917 2053918 2053919 2053920 2056083 2053915 2056082 2048400 2056429 2056430 2056431 2057399 2057400 2057401
• Recalling Firm/ Manufacturer: Smith & Nephew, Inc.; 150 Minuteman Rd; Andover MA 01810-1031
• Manufacturer Reason for Recall: Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch
• FDA Determined Cause: Equipment maintenance
• Action: Smith & Nephew issued Urgent Medical Device Recall letter (R-2020-19) FSN on September 9, 2020 via email or overnight mail to customers that received affected products. 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 enclosed with 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 below. 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 FieldActions@smith-nephew.com. 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 FieldActions@smith-nephew.com.
• Quantity in Commerce: 263,874 (total)
• Distribution: Nationwide Foreign: AE, AT, AU, BE, BM, BR, CA, CH, CL, CN, CO, CY, CZ, DE, DK, DO, EC, EE, ES, FI, FR, GB, GE, GR, HK, HU, IE, IL, IN, IT, JP,KR, LV,MY, NL, NO, PA,PE, PL, PR, PT, RU, SE, SG, SI, TH, TR, TW, UA, & ZA
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = MAI and Original Applicant = Smith & Nephew, Inc.