Z-1637-2014Class II

TRIGEN INTERTAN 1.5 NAIL: (1) REF 71676515, 10 MM X 10 CM, 125 degree, LEFT, (2) REF 71676556, 11.5 MM X 36...

Name: Z-1637-2014 TRIGEN INTERTAN 1.5 NAIL: (1) REF 71676515, 10 MM X 10 CM, 125 degree, LEFT, (2) REF 71676556, 11.5 MM X 36...
Creator: Smith & Nephew Inc
Published: 2014-04-04
License: https://open.fda.gov/license/

Smith & Nephew, Inc. / initiated 2014-04-04 / Terminated / root cause: manufacturing process

FDA source

Smith & Nephew Inc began a recall of TRIGEN INTERTAN 1.5 NAIL: (1) REF 71676515, 10 MM X 10 CM, 125 degree, LEFT, (2) REF 71676556, 11.5 MM X 36 CM, 125 degree, RIGHT, (3) REF 71676558, 11.5 MM X... on 2014-04-04. FDA classified it as Class II and gives the reason as "A manufacturing error resulted in the set screw being inserted too deep in the affected nails". 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-1637-2014
Classification: Class II
Status: Terminated
Initiated: 2014-04-04
Posted: 2014-05-20
Terminated: 2017-07-01
Recalling firm: Smith & Nephew, Inc.
Product: TRIGEN INTERTAN 1.5 NAIL: (1) REF 71676515, 10 MM X 10 CM, 125 degree, LEFT, (2) REF 71676556, 11.5 MM X 36 CM, 125 degree, RIGHT, (3) REF 71676558, 11.5 MM X 38 CM, 125 degree, RIGHT, (4) REF 71676561, 11.5 MM X 42 CM, 125 degree, LEFT, Smith & Nephew, Inc. Orthopedic fixation device.
Product code: JDS Nail, Fixation, Bone
Reason for recall: A manufacturing error resulted in the set screw being inserted too deep in the affected nails.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: The firm initiated the recall via an "Urgent - Product Recall 1st Notification - Urgent" letter and e-mail on 04/04/2014, identifying the product, explaining the problem, and the potential risk associated with using the product. Customers are to inspect their inventory, and locate and quarantine any affected product. Additionally, the Inventory Return Certification form should be completed and returned along with any affected product identified, once a Return Authorization number has been obtained from Smith & Nephew's Safety Affairs Department.
Quantity in commerce: 1,253 units total
Distribution: Worldwide Distribution -- USA, France, Germany, Sweden, Switzerland, UK, Canada, Australia, Japan, China, India, Dubai, South Africa, South Korea, Mexico, and Venezuela.
Product codes and lots: (1) REF 71676515, Lot Number 13LT36602 (2) REF 71676556, Lot Numbers: 13LT36604, 13MT37354, 13MT37947, 14AT38705, 14AT38714 (3) REF 71676558, Lot Numbers: 13KT36282, 13MT37356, 13MT37664, 13MT37949, 14AT38187 (4) REF 71676561, Lot Numbers: 13LT36605, 13MT37358, 14AT38188

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1637-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1636-2014	Class II	Terminated	Voluntary: Firm initiated	2014-05-28	2014-05-20
Z-1637-2014	Class II	Terminated	Voluntary: Firm initiated	2014-05-28	2014-05-20

Product code JDS

K040212Class IITrigen IntertanSmith & Nephew, Inc. / cleared 2004-02-20

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)