Z-1132-2013Class II

TRIGEN (TM) L-P SCREW, 4.5 MM X 37.5 MM, TI-6AL-4V, QTY: (1), STERILE R, REF 71645437, Smith & Nephew, Inc...

Name: Z-1132-2013 TRIGEN (TM) L-P SCREW, 4.5 MM X 37.5 MM, TI-6AL-4V, QTY: (1), STERILE R, REF 71645437, Smith & Nephew, Inc...
Creator: Smith & Nephew Inc
Published: 2013-03-06
License: https://open.fda.gov/license/

Smith & Nephew, Inc. / initiated 2013-03-06 / Terminated / root cause: manufacturing process

FDA source

Smith & Nephew Inc began a recall of TRIGEN (TM) L-P SCREW, 4.5 MM X 37.5 MM, TI-6AL-4V, QTY: (1), STERILE R, REF 71645437, Smith & Nephew, Inc. Memphis, TN 38116 USA orthopedic surgery on 2013-03-06. FDA classified it as Class II and gives the reason as "One batch of 4.5 mm diameter Trigen Low-Profile Bone Screws were incorrectly anodized with a gold coating (indicating a 5 mm diameter) instead of a gray coating (indicating a 4.5 mm diameter)". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1132-2013
Classification: Class II
Status: Terminated
Initiated: 2013-03-06
Posted: 2013-04-17
Terminated: 2019-08-16
Recalling firm: Smith & Nephew, Inc.
Product: TRIGEN (TM) L-P SCREW, 4.5 MM X 37.5 MM, TI-6AL-4V, QTY: (1), STERILE R, REF 71645437, Smith & Nephew, Inc. Memphis, TN 38116 USA orthopedic surgery
Product code: HSB Rod, Fixation, Intramedullary And Accessories
Reason for recall: One batch of 4.5 mm diameter Trigen Low-Profile Bone Screws were incorrectly anodized with a gold coating (indicating a 5 mm diameter) instead of a gray coating (indicating a 4.5 mm diameter).
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Smith & Nephew sent an Urgent Product Recall Notification letter dated March 6, 2013, to all affected customers. The 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 affected product and quarantine for return. Non-responding consignees were notified again on March 15, 2013, by email. Surgeons were to be notified by letter beginning on March 20, 2013. For questions regarding this recall call 978-749-1330.
Quantity in commerce: 23 units
Distribution: Nationwide Distribution including CA, FL, GA, MA, MI, NC, SC, OH, and MO.
Product codes and lots: Lot Number 12FM12182

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1132-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1132-2013	Class II	Terminated	Voluntary: Firm initiated	2013-04-24	2013-04-17

Product code HSB

K111025Class IITrigen Low Profile Bone ScrewSmith & Nephew, Inc. / cleared 2011-07-01

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)