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U.S. Department of Health and Human Services

Class 2 Device Recall Smith & Nephew

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  Class 2 Device Recall Smith & Nephew see related information
Date Initiated by Firm September 10, 2015
Date Posted October 22, 2015
Recall Status1 Terminated 3 on June 23, 2021
Recall Number Z-0157-2016
Recall Event ID 72205
510(K)Number K964215  
Product Classification Instrument, surgical, orthopedic, ac-powered motor and accessory/attachment - Product Code HWE
Product Smith & Nephew MOSAICPLASTY DP- Disposable Harvesting System 6.5 mm, Sterile
Part Number: 7209236

Intended Use: For arthroscopic (knee and ankle) and open osteochondral grafting fix for osteochondral (cartilage) defects.
Code Information 567531 50182767 50242031 50311086 50354626 50396028 50419909 50451050 50481583 586717 50193108 50251239 50311900 50361147 50400191 50423797 50451742 L50195027 50023445 50195027 50254749 50322127 50372399 50402518 50427083 50452777 50031093 50200477 50257710 50326789 50375128 50404802 50431408 50455222 50089906 50207485 50260093 50331945 50376693 50405482 50432856 50456255 50112893 50214248 50266143 50337081 50379780 50408076 50433676 50460255 50129647 50218992 50279513 50337265 50381258 50408437 50442599 50469461 50160551 50221872 50285674 50337464 50389830 50411651 50443725 50476967 50175558 50230673 50297948 50344790 50389832 50414388 50447281 50477073 50179006 50236269 50302624 50348085 50395177 50414909 50448747 50480681
Recalling Firm/
Manufacturer
Smith & Nephew, Inc., Endoscopy Div.
130 Forbes Blvd
Mansfield MA 02048
For Additional Information Contact Same
978-749-1000
Manufacturer Reason
for Recall
Sterility of device is compromised due to breach in the packaging
FDA Determined
Cause 2
Package design/selection
Action Smith & Nephew issued Recall Notification Letter dated September 10, 2015 via overnight Federal Express. Customers were requested to inspect inventory and locate any unused devices from the above listed product and batch numbers, and quarantine them immediately. Complete the Inventory Return Certification Form on the following page, indicating the lot numbers and quantities that need to be returned and include your phone and fax number in the spaces provided. If you do not have product to return, please place an x in the column No product to return. Send the completed form to the Smith & Nephew's Field Action Department via email at FieldActions@smithnephew. com or fax +1-901-566-7975 to obtain a return authorization (RA) number. Return any affected product to the address listed on the Inventory Return Certification Form. Please indicate the RA number on your return shipment.
Quantity in Commerce 1347 units
Distribution Worldwide Distribution - US Nationwide, Canada, Austria, Australia, Belgium, China, Spain, Finland, France, Great Britain, Greece, Germany, Hungary, India, Italy, Japan, Korea, Lithuania, Latvia, Netherlands, Poland, Portugal, Sweden, Thailand, Turkey, Ukraine and Venezuela
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 = HWE and Original Applicant = SMITH & NEPHEW ENDOSCOPY, INC.
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