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U.S. Department of Health and Human Services

Class 2 Device Recall HEALICOIL RSB SA 5.5MM W/1 UT & 1 UB BL Absorbable Suture anchor

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 Class 2 Device Recall HEALICOIL RSB SA 5.5MM W/1 UT & 1 UB BL Absorbable Suture anchorsee related information
Date Initiated by FirmSeptember 09, 2020
Create DateOctober 21, 2020
Recall Status1 Open3, Classified
Recall NumberZ-0173-2021
Recall Event ID 86462
510(K)NumberK151105 
Product Classification Fastener, fixation, biodegradable, soft tissue - Product Code MAI
ProductHEALICOIL RSB SA 5.5MM W/1 UT & 1 UB BL- Absorbable Suture anchor Product Number: 72203801
Code Information Batch Numbers: 2013918 2016156 2017774 2018804 2021456 2023227 2024815 2025049 2027438 2029400 2029401 2033291 2033290 2034431 2034432 2034499 2034500 2034501 2034502 2035698 2037194 2039456 2045894 2048429 2048430 2051045 2051046 2049950 2049951 2053927 2056086 2056434 
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 2
Equipment maintenance
ActionSmith & 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 Commerce263,874 (total)
DistributionNationwide 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 CycleTPLC 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) Database510(K)s with Product Code = MAI
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