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U.S. Department of Health and Human Services

Class 2 Device Recall Smith & Nephew FOOTPRINT Ultra PK Suture Anchor

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  Class 2 Device Recall Smith & Nephew FOOTPRINT Ultra PK Suture Anchor see related information
Date Initiated by Firm March 17, 2020
Create Date April 22, 2020
Recall Status1 Open3, Classified
Recall Number Z-1757-2020
Recall Event ID 85296
510(K)Number K093897  
Product Classification Fastener, fixation, nondegradable, soft tissue - Product Code MBI
Product Smith & Nephew FOOTPRINT Ultra PK Suture Anchor, 5.5mm
Part Number: 72202902
Code Information Lot Numbers: 2013889 2013916 2013955 2014296 2016197 2016198 2016232 2016233 2016234 2017395 2017761 2017818 2017819 2018639 2018801 2018855 2019841 2019893 2019992 2021327 2021390 2021391 2021499 2022264 2022265 2022266 2022267 2024809 2025064 2025065 2025165 2025169 2025343 2025386 2027398 2027429 2028620 2029251 2029252 2029253 2029254 2029295 2029296 2029297 2029298 2029337 2029338 2029339 2029340 2029386 2029387 2030937 2030938 2030939 2030940 2031077 2031078 2031079 2031080 2031145 2032812 2032813 2032814 2032815 2033272 2033273 2033387 2033388 2033389 2033390 2033391 2033517 2033518 2033519 2033520 2033521 2033522 2033523 2033524 2033525 2033526 2033527 2033528 2033664 2034417 2034418 2034482 2034483 2036298 2036299 2036704 2036705 2037123 2037124 2037125 2037171 2037176 2038315 2038316 2038449 2038452 2038785 2038786 2038787 2038788 2038919 2039245 2039247 2039436 2039437 2039438 2040097 2040098 2040099 2040100 2040101 2040727 2040728 2040729 2041051 2041052 2041053 2041054 2041055 2041194 2041195 2041196 2041197 2041198 2041780 2041781 2041782 2042582 2042583 2042584 2042763 2042764 2042765 2044884 2044885 2044886 2044887 2044888 2045848 50532035 50598665 50670645 50721923 50721924 50722153 50722409 50723724 50723725 50723729 50724822 50725155 50725156 50726258 50726558 50726559 50730869 50730870 50730871 50730872 50730876 50730877 50734025 50734026 50734031 50734035 50734038 50734041 50736231 50736234 50737178 50737941 50737942 50738087 50738088 50738894 50738895 50738896 50742394 50742585 50742586 50744052 50744053 50744054 50744777 50745439 50745440 50745441 50746623 50746624 50746625 50747145 50747146 50747859 50747860 50748081 50748082 50748083 50748084 50751684 50753515 50753518 50760611 50760612 50760613 50760614 50760802 50760803 50760805 50760806 50760807 50766818 50766828 50769166 50769167 50769168 50773888 50774344 50776630 50776631 50785146 50785147 50785261 50785262 50785263 50785505 50785506 50793871 50795930 50795933 50795936 50803204 50803205 50807430 50807431 50811207 50811209 50815810 50815812 50821889 50821892 50831271 50831742 
Recalling Firm/
Manufacturer		 Smith & Nephew, Inc.
130 & 120 Forbes Blvd
Mansfield MA 02048
For Additional Information Contact SAME AS ABOVE
508-261-3600
Manufacturer Reason
for Recall		 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.
FDA Determined
Cause 2		 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, 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 FieldActions@smith-nephew.com 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 FieldActions@smith-nephew.com.
Quantity in Commerce 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
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 = MBI and Original Applicant = SMITH & NEPHEW INC., ENDOSCOPY DIV.
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