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U.S. Department of Health and Human Services

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

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  Class 2 Device Recall HEALICOIL RG SA 5.5MM W/2 UBBL CBR BL Absorbable Suture anchor see related information
Date Initiated by Firm September 09, 2020
Create Date October 21, 2020
Recall Status1 Open3, Classified
Recall Number Z-0170-2021
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/2 UB-BL CBR BL-- Absorbable Suture anchor
Product Number: 72203706
Code Information Batch Numbers: 2013923 2013951 2013987 2016163 2017827 2017828 2018645 2018644 2018753 2020065 2021559 2024738 2024839 2025433 2025435 2025436 2025367 2027468 2027435 2027501 2029263 2029398 2031090 2031091 2034427 2034428 2035537 2035538 2035539 2036725 2041201 2041202 2045870 2045869 2048392 2048394 2048395 2049915 2049916 2052172 2052173 2052174 2052175 2052177 2048393 2056427 2056428 
Recalling Firm/
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 2
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.