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U.S. Department of Health and Human Services

Class 2 Device Recall WHIPKNOT Soft Tissue Cinch

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  Class 2 Device Recall WHIPKNOT Soft Tissue Cinch see related information
Date Initiated by Firm July 19, 2016
Create Date September 07, 2016
Recall Status1 Terminated 3 on July 10, 2018
Recall Number Z-2745-2016
Recall Event ID 74771
510(K)Number K952535  
Product Classification Fastener, fixation, biodegradable, soft tissue - Product Code MAI
Product Smith & Nephew Whipknot Soft Tissue Cinch (USP#5) suture. PN: 7211015 Used during ligament reconstruction.
Code Information Lot codes: 50387867 50388745 50389780 50390947 50392219 50392401 50393765 50394079 50395093 50396528 50396841 50397925 50399974 50400293 50401451 50402461 50402959 50403376 50403941 50405570 50406358 50407001 50407434 50407950 50407951 50408878 50409545 50410397 50411389 50412044 50413155 50414113 50415145 50415520 50415873 50416326 50416832 50417399 50417668 50418103 50418994 50420164 50421033 50421623 50422190 50422891 50422892 50423320 50424442 50424933 50426325 50427350 50428379 50429275 50429625 50433984 50434656 50436573 50437136 50437526 50437759 50438338 50439087 50439765 50439766 50440062 50440837 50441687 50442651 50442880 50444065 50446669 50446768 50446770 50448070 50448602 50449028 50450098 50450473 50451227 50452947 50453834 50454699 50456357 50457059 50457933 50458614 50460363 50461194 50462494 50463802 50464798 50466235 50466505 50467033 50467808 50468830 50469933 50471415 50472190 50473438 50474159 50475156 50475855 50477527 50478007 50478622 50479617 50481285 50481730 50483050 50483361 50485995 50487659 50488891 50492846 50492847 50492848 50492849 50492851 50492852 50493064 50493806 50494458 50495857 50496836 50498479 50499120 50499121 50500273 50502177 50503259 50503943 50505008 50506627 50507250 50507728 50508689 50510084 50513573 50514115 50515369 50516858 50517711 50518586 50519608 50519938 50521068 50521840 50522157 50522313 50522481 50522791 50523907 50524119 50524707 50525171 50526231 50526605 50527117 50527848 50528880 50529519 50529834 50530093 50530468 50530782 50530799 50531351 50531553 50532380 50532717 50533143 50533646 50534235 50534638 50537501 50549463 50549468 50553176 50553177 50553178 50553585 50554431 50555221 50555642 50556017 50556125 50558051 50559082 50560192 50560193 50562713 50563407 50565147 50565408 50567384 50569692 50570896 50572075 50574212 50575366 50577597 50578036 50578037 50579348 50580730 50581344 50583475 50584361 50584362 50584363 50586084 50586561 50588245 50589286 50590542 50591919 50592295 50594969 50598322 50599811 50603228 50603355 50603357 50603972 50604722 50605882 
Recalling Firm/
Manufacturer
Smith & Nephew, Inc.
130 & 120 Forbes Blvd
Mansfield MA 02048
For Additional Information Contact
508-261-3600
Manufacturer Reason
for Recall
Sterility compromised due to breach in sterile packaging
FDA Determined
Cause 2
Package design/selection
Action Smith & Nephew issued recall letters via Federal Express on July 19, 2016 to the customers. Customers asked to inspect inventory and locate any unused devices, and quarantine immediately. Contact Smith & Nephews Field Actions Department via email at FieldActions@smith-nephew.com or fax +1-901-566-7975 to return the completed Inventory Return Certification Form and obtain a return authorization (RA) number if you have product to return.
Quantity in Commerce 34,065 units
Distribution Worldwide distribution. US nationwide, and the countries of: AU, AT, BE, CA, CH, CR, DB, DE, ES, FI, FR, GB, GR, IC, IL, IN, IT, MY, NL, NO, PL, PR, PT,SE, SG, TH, and 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = MAI and Original Applicant = ACUFEX MICROSURGICAL, INC.
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