Z-1718-2012

6.5 MM CANELLOUS TAP W/ QUICK CONNECT, REF 71173509, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN...

Name: Z-1718-2012 6.5 MM CANELLOUS TAP W/ QUICK CONNECT, REF 71173509, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN...
Creator: Smith & Nephew Inc
Published: 2012-04-13
License: https://open.fda.gov/license/

Smith & Nephew, Inc. / initiated 2012-04-13 / Terminated / root cause: packaging

FDA source

Smith & Nephew Inc began a recall of 6.5 MM CANELLOUS TAP W/ QUICK CONNECT, REF 71173509, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 38116 Orthopedic surgical device on 2012-04-13. The reason FDA records is "Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch, voiding sterility". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1718-2012
Status: Terminated
Initiated: 2012-04-13
Posted: 2012-06-06
Terminated: 2015-09-22
Recalling firm: Smith & Nephew, Inc.
Product: 6.5 MM CANELLOUS TAP W/ QUICK CONNECT, REF 71173509, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 38116 Orthopedic surgical device.
Product code: HWX Tap, Bone
Reason for recall: Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch, voiding sterility.
Root cause tag: packaging
FDA root cause: Packaging
Action: Smith & Nephew Sales Representatives and Smith & Nephew International Distributors were notified of the problem with the affected product and the recall via email on April 13, 2012. All affected direct consignees were notified via Fed Ex on April 13, 2012. The Urgent Medical Device Recall letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to cease use and distribution of the product and quarantine them immediately for return. Customers were instructed to complete the Inventory Return Certification Form included with the letter. Customers should fax or email the form to 901-566-7975 or [email protected]. The affected product should be returned to: Smith & Nephew Attn: Global Field Actions Safety Affairs 1450 Brooks Road Memphis, Tennessee 38116 If the affected product was distributed further customers were instructed to provide a copy of the recall letter to these customers.
Quantity in commerce: 265 units
Distribution: Worldwide Distribution - USA (nationwide) and the countries of Australia, Malaysia, Germany, Japan, Portugal, United Arab Emirates, Spain, France, South Africa, Norway, Sweden, Denmark, Switzerland, Belgium, China, The Netherlands, Finland, Mexico, Italy, UK, Venezuela, Colombia, Thailand, Chile, South Korea, India, and Turkey
Product codes and lots: Lot Numbers: 07EHU0005, 09HHU0015, 09HHU0016, 10EHU0010, 10JHU0004

Product code HWX

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)