Z-2443-2023Class II

TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 36CM 130 DEGREE LEFT, REF 71647336, Femur nail

Name: Z-2443-2023 TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 36CM 130 DEGREE LEFT, REF 71647336, Femur nail
Creator: Smith & Nephew, Inc.
Published: 2023-07-24
License: https://open.fda.gov/license/

Smith & Nephew, Inc. / initiated 2023-07-24 / Open, Classified / root cause: manufacturing process

FDA source

Smith & Nephew, Inc. began a recall of TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 36CM 130 DEGREE LEFT, REF 71647336, Femur nail on 2023-07-24. FDA classified it as Class II and gives the reason as "A complaint was received indicating that a package contained a TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 40CM 130 DEGREE LEFT implant instead of a TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 36CM 130 DEGREE...". 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-2443-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-07-24
Posted: 2023-08-22
Recalling firm: Smith & Nephew, Inc.
Product: TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 36CM 130 DEGREE LEFT, REF 71647336, Femur nail
Product code: HSB Rod, Fixation, Intramedullary And Accessories
Reason for recall: A complaint was received indicating that a package contained a TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 40CM 130 DEGREE LEFT implant instead of a TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 36CM 130 DEGREE LEFT as described on the product label.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Smith & Nephew issued an Urgent Medical Device Recall Notice on 07/24/2023. The notice explained the problem with the product, the potential risk, and requested the consignees locate and quarantine the affected product for return. Sales reps, district offices, or distributors were directed to notify their customers and ensure that the required actions were complete. The firm is seeking return of the affected product.
Quantity in commerce: 30 units
Distribution: US, AE, CA, DE, ES, GB, MX, PA, PL
Product codes and lots: UDI/DI 03596010500922, Batch Number 21KSM0598

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2443-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2443-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-08-30	2023-08-22
Z-2444-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-08-30	2023-08-22

Product code HSB

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)