Z-0097-2018Class II

smith&nephew TRIGEN INTERTAN 10S, REF 71675384, 10 MM X 18 CM NAIL, 130o (degrees), SET SCREW PREASSEMBLED IN...

Name: Z-0097-2018 smith&nephew TRIGEN INTERTAN 10S, REF 71675384, 10 MM X 18 CM NAIL, 130o (degrees), SET SCREW PREASSEMBLED IN...
Creator: Smith & Nephew, Inc.
Published: 2017-10-24
License: https://open.fda.gov/license/

Smith & Nephew, Inc. / initiated 2017-10-24 / Open, Classified / root cause: manufacturing process

FDA source

Smith & Nephew, Inc. began a recall of smith&nephew TRIGEN INTERTAN 10S, REF 71675384, 10 MM X 18 CM NAIL, 130o (degrees), SET SCREW PREASSEMBLED IN NAIL on 2017-10-24. FDA classified it as Class II and gives the reason as "A single lot of INTERTAN 10S 10 MM X 18 CM 130 D was manufactured with the screw inserted upside down". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0097-2018
Classification: Class II
Status: Open, Classified
Initiated: 2017-10-24
Posted: 2017-11-16
Recalling firm: Smith & Nephew, Inc.
Product: smith&nephew TRIGEN INTERTAN 10S, REF 71675384, 10 MM X 18 CM NAIL, 130o (degrees), SET SCREW PREASSEMBLED IN NAIL
Product code: JDS Nail, Fixation, Bone
Reason for recall: A single lot of INTERTAN 10S 10 MM X 18 CM 130 D was manufactured with the screw inserted upside down.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: Smith & Nephew sent an Urgent Medical Device Recall Notice dated October 24, 2017, to all affected customers. The firm requested return of the product. Please follow the instructions on the attached Response Form. For further questions, please call (978) 749-1440.
Quantity in commerce: 17 units
Distribution: US Distribution - TN, IL, CT, MO, CA., and Internationally to Italy and Germany
Product codes and lots: Lot number 16LM07111

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0097-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0097-2018	Class II	Ongoing	Voluntary: Firm initiated	2017-11-22	2017-11-16

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)