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U.S. Department of Health and Human Services

Class 2 Device Recall Smith & Nephew Aimer Endofemoral

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 Class 2 Device Recall Smith & Nephew Aimer Endofemoralsee related information
Date Initiated by FirmApril 29, 2010
Date PostedOctober 12, 2010
Recall Status1 Terminated 3 on May 09, 2012
Recall NumberZ-0048-2011
Recall Event ID 55602
Product Classification Acessories, arthroscopic - Product Code NBH
ProductSmith & Nephew Aimer Endofemoral 4mm Offset (Green) Catalog Number: 72201716F (Refurbished) ACUFEX Surgical Instruments are intended for use in orthopedic and general surgery.
Code Information Lot Numbers: 50283055,50296495  
Recalling Firm/
Manufacturer		 Smith & Nephew, Inc. Endoscopy Division
150 Minuteman Drive
Andover MA 01810-1031
For Additional Information ContactSAME
978-749-1073
Manufacturer Reason
for Recall		Endofemoral Aimer tip may separate due to failure of the soldered joint
FDA Determined
Cause 2		Component design/selection
ActionSmith & Nephew sent a "Medical Device Recall Information" letter dated April 29, 2010, with an attached "Urgent-Product Recall 1st Notification - Urgent" response form via Federal Express on April 29, 2010, to all customers. An e-mail was sent to the contacts in the identified OUS countries alerting them of the recall. ( Note: On June 24, 2010, the firm expanded the recall to include 4 additional catalog numbers 7220l713F, 72201714F, 72201715F, 722017l6F that are refurbished and one additional lot number to catalog Number: 72201714.) The letter described the product, problem and action to be taken by customers. The customers were instructed to immediately check stock for affected product; immediately remove the items from stock and set aside for quarantine; complete and return the attached Urgent-Product Recall 1st Notification - Urgent" response form, even if no product is being returned, via fax at +1-508-261-3636 attention Cindy Burns or email a PDF to Cindy.Burns@smith-nephew.com; call for a return Authorization number at 1-800-343-5717 Option #3, and return product to Smith & Nephew, Inc., Endoscopy Division as soon as possible. If you have any questions or require additional information, please contact Cindy Burns at 1-508-261-3655.
Quantity in Commerce7 units
DistributionWorldwide distribution: USA and countries including: Australia, Austria, Belgium, Brazil, Canada, Costa Rica, Denmark. Dubal, Finland, France. Germany, Greece, Hong Kong, India, Italy, Japan, Malaysia, Netherlands. Norway, Portugal, Puer To Rico, Singapore. South Africa, Spain. Sweden, Switzerland, Taiwan, Turkey, United Kingdom, and Venezuela.
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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