FDA Device Recall Z-0042-2011: Smith & Nephew, Inc. Endoscopy Division

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0042-2011.

Recall Res Number

Z-0042-2011

Recalling Firm / Manufacturer

Smith & Nephew, Inc. Endoscopy Division

FEI Number

3003604053

Recall Status

Terminated

Recall Classification

N/A

Date Initiated

2010-04-29

Date Posted

2010-10-12

Date Terminated

2012-05-09

Product Code

NBH

Event Number

55602

Product Quantity

811 units

Product Description Smith & Nephew Aimer Endofemoral 5mm Offset (Red) Catalog Number: 72201715 ACUFEX Surgical Instruments are intended for use in orthopedic and general surgery.

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

Action Details 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.

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.

Code Information / Serial Numbers Lot Numbers: 50257058, 50270509, 50275311, 50278013, 50291509, 50294879, 50302647, 50304212, 502780131

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Medical Device Recall: Z-0042-2011

Recall Parameters & Description

Related Establishments / Registrations

Public Record Disclaimer