Z-0944-2013Class II

INTERNAL HEX RECON SCREW, TI-6AL-4V, REF 7162375, TRIGEN (R) INTERNAL HEX CAPTURED RECON SCREW, QTY: (1), 6.4...

Name: Z-0944-2013 INTERNAL HEX RECON SCREW, TI-6AL-4V, REF 7162375, TRIGEN (R) INTERNAL HEX CAPTURED RECON SCREW, QTY: (1), 6.4...
Creator: Smith & Nephew Inc
Published: 2013-02-07
License: https://open.fda.gov/license/

Smith & Nephew, Inc. / initiated 2013-02-07 / Terminated / root cause: labeling and UDI

FDA source

Smith & Nephew Inc began a recall of INTERNAL HEX RECON SCREW, TI-6AL-4V, REF 7162375, TRIGEN (R) INTERNAL HEX CAPTURED RECON SCREW, QTY: (1), 6.4 MM, 75 MM, TITANIUM, Smith & Nephew, Inc... on 2013-02-07. FDA classified it as Class II and gives the reason as "75 mm screws were packaged and labeled using an 80 mm screw outer box and label, while 80 mm screws were packaged and labeled using a 75 mm screw outer box and label". 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-0944-2013
Classification: Class II
Status: Terminated
Initiated: 2013-02-07
Posted: 2013-03-13
Terminated: 2016-01-11
Recalling firm: Smith & Nephew, Inc.
Product: INTERNAL HEX RECON SCREW, TI-6AL-4V, REF 7162375, TRIGEN (R) INTERNAL HEX CAPTURED RECON SCREW, QTY: (1), 6.4 MM, 75 MM, TITANIUM, Smith & Nephew, Inc. Orthopedic. Bone screw for intramedullary rod fixation.
Product code: JDS Nail, Fixation, Bone
Reason for recall: 75 mm screws were packaged and labeled using an 80 mm screw outer box and label, while 80 mm screws were packaged and labeled using a 75 mm screw outer box and label.
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: Smith & Nephew sales representatives and Smith & Nephew international distributors were notified of problem and the recall via email on February 7, 2013. They were instructed to cease use and distribution of the product and quarantine for return. Non responding consignees were notified again on February 28, 2013 by email. Hospitals were notified by letter beginning on February 7, 2013. Smith & Nephew also contacted the surgeons who implanted the screws by letter the week of February 11th. For questions regarding this recall call 978-749-1330.
Quantity in commerce: 90 units
Distribution: Worldwide Distribution - USA including NM, TN, TX, NC, CA, MI, KY, MA, NJ, OH, and HI. Internationally to Canada, United Arab Emirates, Mexico, Argentina, Japan, and Chile.
Product codes and lots: Batch Number 12JM17051

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0944-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0943-2013	Class II	Terminated	Voluntary: Firm initiated	2013-03-20	2013-03-13
Z-0944-2013	Class II	Terminated	Voluntary: Firm initiated	2013-03-20	2013-03-13

Product code JDS

K981529Class IITitanium Intramedullary Nail, Titanium Locking ScrewSmith & Nephew, Inc. / cleared 1998-07-09

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)