Smith & Nephew Aimer Endofemoral 4mm Offset (Red) Catalog Number: 72201715F (Refurbished) ACUFEX Surgical Instruments are intended for use in orthopedic and general surgery.
This recall has been terminated (originally issued October 12, 2010).
- Recall Initiated
- April 29, 2010
- Posted
- October 12, 2010
- Terminated
- May 9, 2012
- Recall Number
- Z-0047-2011
- Quantity
- 10 units
- Firm Location
- Andover, MA
- Official Source
- View on FDA website ↗
Reason for Recall
Endofemoral Aimer tip may separate due to failure of the soldered joint
Distribution
Worldwide 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.
Lot / Code Info
Lot numbers: 50283054, 50296494,50297288
Root Cause
Component design/selection
Action Taken
Smith & 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.