Z-1940-2025Class II

Femoral Nail, RIGHT T2 GTN 8x300 mm. Catalog Number: 1851-0830S

Name: Z-1940-2025 Femoral Nail, RIGHT T2 GTN 8x300 mm. Catalog Number: 1851-0830S
Creator: Stryker GmbH
Published: 2025-05-22
License: https://open.fda.gov/license/

Stryker Corp. / initiated 2025-05-22 / Open, Classified / root cause: labeling and UDI

FDA source

Stryker GmbH began a recall of Femoral Nail, RIGHT T2 GTN 8x300 mm. Catalog Number: 1851-0830S on 2025-05-22. FDA classified it as Class II and gives the reason as "Investigation determined that one lot of the T2 Greater Trochanter Nail (GTN) was labeled as left version but contained a right nail and another lot was labeled as right version but contained a left nail". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1940-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-05-22
Posted: 2025-06-10
Recalling firm: Stryker Corp.
Product: Femoral Nail, RIGHT T2 GTN 8x300 mm. Catalog Number: 1851-0830S.
Product code: HSB Rod, Fixation, Intramedullary And Accessories
Reason for recall: Investigation determined that one lot of the T2 Greater Trochanter Nail (GTN) was labeled as left version but contained a right nail and another lot was labeled as right version but contained a left nail.
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by firm
Action: Stryker notified consignees on about 05/22/2025 via letter. Consignees were instructed to immediately check their inventory for affected units and quarantine any on hand, and complete and return the Business Reply Form by email to . Upon receipt of the completed Business Reply Form, Stryker will contact customers to arrange for the return of their product(s). If consignees have further distributed the product, they were instructed to notify their customers.
Quantity in commerce: 2
Distribution: Worldwide - US Nationwide distribution in the states of California and Missouri. The countries of Belgium, Japan, Netherlands.
Product codes and lots: Catalog Number: 1851-0830S. GTIN: 04546540647184. Batch lot number: K09F17F

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1940-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1939-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-06-18	2025-06-10
Z-1940-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-06-18	2025-06-10

Product code HSB

K101438Class IIT2 Greater Trochanter NailHowmedica Osteonics Corp. / cleared 2010-06-17

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)