Z-1914-2025Class II

Long Nail, RIGHT Gamma4 10x320mm x 125, component of the Gamma4 System. Catalog Number: 84250320S

Name: Z-1914-2025 Long Nail, RIGHT Gamma4 10x320mm x 125, component of the Gamma4 System. Catalog Number: 84250320S
Creator: Stryker GmbH
Published: 2025-05-28
License: https://open.fda.gov/license/

Stryker Corp. / initiated 2025-05-28 / Open, Classified / root cause: manufacturing process

FDA source

Stryker GmbH began a recall of Long Nail, RIGHT Gamma4 10x320mm x 125, component of the Gamma4 System. Catalog Number: 84250320S on 2025-05-28. FDA classified it as Class II and gives the reason as "Investigation confirmed that the GAMMA4 Right Long Nail was manufactured with the geometry of a left nail". 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-1914-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-05-28
Posted: 2025-06-06
Recalling firm: Stryker Corp.
Product: Long Nail, RIGHT Gamma4 10x320mm x 125, component of the Gamma4 System. Catalog Number: 84250320S.
Product code: HSB Rod, Fixation, Intramedullary And Accessories
Reason for recall: Investigation confirmed that the GAMMA4 Right Long Nail was manufactured with the geometry of a left nail.
Root cause tag: manufacturing process
FDA root cause: Process design
Action: Stryker notified consignees on about 05/28/2025 via FedEx letter. Consignees were instructed to review inventory and immediately quarantine any affected units on hand, and complete and return the Business Reply Form documenting receipt and product segregation. Upon receipt of the response form, Stryker will contact consignees to arrange for return of the affected units. If affected products have been further distributed, consignees were instructed to notify those customers and let Stryker know.
Distribution: Worldwide - US Nationwide distribution in the states of AL, FL, NJ, OR and the countries of Australia and Japan.
Product codes and lots: Catalog Number: 84250320S. GTIN: 07613327479515. Lot Number: K1BC9B7.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1914-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1914-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-06-18	2025-06-06

Product code HSB

K213328Class IIGamma4 System, Gamma3 System, IMN Screws System, T2 Tibial Nailing SystemStryker GmbH / cleared 2022-02-11

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)