—#91310

Product

Smith & Nephew Aimer Endofemoral 4mm Offset (Purple Catalog Number: 72201714 ACUFEX Surgical Instruments are intended for use in orthopedic and general surgery.

FDA product code: NBH — Accessories, Arthroscopic
Device class: Class 1
Medical specialty: Orthopedic
Affected lot / code info: Lot Numbers: 50257057, 50270508, 50275310, 50278012, 50291506, 50294878, 50305399,502753101, 501753101

Why it was recalled

Endofemoral Aimer tip may separate due to failure of the soldered joint

Root cause (FDA determination)

Component design/selection

Action the firm took

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.

Recalling firm

Firm: Smith & Nephew, Inc. Endoscopy Division
Address: 150 Minuteman Drive, Andover, Massachusetts 01810-1031

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2010-04-29
Posted by FDA: 2010-10-12
Terminated: 2012-05-09
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #91310. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.