Z-2646-2011

Smith & Nephew Hip Arthroscopy Repair Instrument Tray Part Number: 72202732 Device Description-The Smith &...

Name: Z-2646-2011 Smith & Nephew Hip Arthroscopy Repair Instrument Tray Part Number: 72202732 Device Description-The Smith &...
Creator: Smith & Nephew, Inc. Endoscopy Division
Published: 2011-05-19
License: https://open.fda.gov/license/

Smith & Nephew, Inc. / initiated 2011-05-19 / Terminated / root cause: labeling and UDI

FDA source

Smith & Nephew, Inc. Endoscopy Division began a recall of Smith & Nephew Hip Arthroscopy Repair Instrument Tray Part Number: 72202732 Device Description-The Smith & Nephew Hip Arthroscopy Repair Instrument Tray is... on 2011-05-19. The reason FDA records is "Hip Arthroscopy Repair Instrument Tray shipped with an incorrect Instructions For Use (IFU)". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2646-2011
Status: Terminated
Initiated: 2011-05-19
Posted: 2011-06-24
Terminated: 2012-05-09
Recalling firm: Smith & Nephew, Inc.
Product: Smith & Nephew Hip Arthroscopy Repair Instrument Tray Part Number: 72202732 Device Description-The Smith & Nephew Hip Arthroscopy Repair Instrument Tray is designed to contain and protect reusable surgical instruments during transport, sterilization, and storage and to allow optimal exposure of the tray's contents to sterilant during the sterilization process. The instrument tray is a perforated stainless steel case with a latchable lid and handle. The tray is fitted with nylon coated aluminum holders, silicone instrument holders, and a protective mat. The instrument tray is marked to facilitate organized instrument placement.
Product code: KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Reason for recall: Hip Arthroscopy Repair Instrument Tray shipped with an incorrect Instructions For Use (IFU)
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: Smith & Nephew sent an "URGENT FIELD CORRECTION NOTIFICATION" letter dated May 19, 2011 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers. Customers were instructed to confirm receipt of the corrected IFU document (10600729 rev B.) and communicate to appropriate facility individuals. Once appropriate individuals are informed, customers were instructed to complete and return information requested at the bottom of the letter. The completed information should be returned to Smith& Nephew via fax at 978-749-1654 or by mail at Smith & Nephew Endoscopy, 150 Minuteman Road, Andover, MA 01810. Questions may be answered by contacting the Manager, QA and Compliance at 978-749-1397.
Quantity in commerce: 11 units
Distribution: Worldwide Distribution--No USA Distribution; countries of Italy, Portugal, United Kingdom, and Venezuela.
Product codes and lots: Lot Number: 48208-1-1B

Product code KCT

K102544Class IISmith & Nephew Hip Arthroscopy Repair Instrument TraySmith & Nephew Inc., Endoscopy Div. / cleared 2011-01-05

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)