Z-0047-2011

Smith & Nephew Aimer Endofemoral 4mm Offset (Red) Catalog Number: 72201715F (Refurbished) ACUFEX Surgical...

Name: Z-0047-2011 Smith & Nephew Aimer Endofemoral 4mm Offset (Red) Catalog Number: 72201715F (Refurbished) ACUFEX Surgical...
Creator: Smith & Nephew, Inc. Endoscopy Division
Published: 2010-04-29
License: https://open.fda.gov/license/

Smith & Nephew, Inc. / initiated 2010-04-29 / Terminated / root cause: design

FDA source

Smith & Nephew, Inc. Endoscopy Division began a recall of Smith & Nephew Aimer Endofemoral 4mm Offset (Red) Catalog Number: 72201715F (Refurbished) ACUFEX Surgical Instruments are intended for use in orthopedic and... on 2010-04-29. The reason FDA records is "Endofemoral Aimer tip may separate due to failure of the soldered joint". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0047-2011
Status: Terminated
Initiated: 2010-04-29
Posted: 2010-10-12
Terminated: 2012-05-09
Recalling firm: Smith & Nephew, Inc.
Product: Smith & Nephew Aimer Endofemoral 4mm Offset (Red) Catalog Number: 72201715F (Refurbished) ACUFEX Surgical Instruments are intended for use in orthopedic and general surgery.
Product code: NBH Accessories, Arthroscopic
Reason for recall: Endofemoral Aimer tip may separate due to failure of the soldered joint
Root cause tag: design
FDA root cause: Component design/selection
Action: 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 [email protected]; 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 commerce: 10 units
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.
Product codes and lots: Lot numbers: 50283054, 50296494,50297288

Product code NBH

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)