Gamma4 Right Long Nail (Stryker) – Incorrect Nail Geometry (2025)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Long Nail, RIGHT Gamma4 10x320mm x 125, component of the Gamma4 System. Catalog Number: 84250320S.
Brand
Stryker GmbH Bohnackerweg 1 Selzach Switzerland
Lot Codes / Batch Numbers
Catalog Number: 84250320S. GTIN: 07613327479515. Lot Number: K1BC9B7.
Products Sold
Catalog Number: 84250320S. GTIN: 07613327479515. Lot Number: K1BC9B7.
Stryker GmbH Bohnackerweg 1 Selzach Switzerland is recalling Long Nail, RIGHT Gamma4 10x320mm x 125, component of the Gamma4 System. Catalog Number: 84250320S. due to Investigation confirmed that the GAMMA4 Right Long Nail was manufactured with the geometry of a left nail.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Investigation confirmed that the GAMMA4 Right Long Nail was manufactured with the geometry of a left nail.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026