FDA Medical Device Recalls (openFDA)
Stryker GmbH: Long Nail, RIGHT Gamma4 10x320mm x 125, component of the Gamma4 System. Catalog Number: 84250320S.
- Recall number
- Z-1914-2025
- Recalling firm
- Stryker GmbH
- Product
- Long Nail, RIGHT Gamma4 10x320mm x 125, component of the Gamma4 System. Catalog Number: 84250320S.
- Status
- Open, Classified
- Initiated
- 2025-05-28
- Posted
- 2025-06-06
- Terminated
- not on file
- Reason
- Investigation confirmed that the GAMMA4 Right Long Nail was manufactured with the geometry of a left nail.
- 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.
- Quantity
- not on file
- Distribution
- Worldwide - US Nationwide distribution in the states of AL, FL, NJ, OR and the countries of Australia and Japan.
- Lot, serial or model codes
- Catalog Number: 84250320S. GTIN: 07613327479515. Lot Number: K1BC9B7.
- 510(k) numbers
- ["K213328"]
- PMA numbers
- not on file
- Product code
- HSB
- Firm FEI
- 3002807830
- Firm city
- Selzach
- Firm state
- not on file
- Firm country
- Switzerland
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28