FDA Medical Device Recalls (openFDA)
Stryker GmbH: Femoral Nail, RIGHT T2 GTN 8x300 mm. Catalog Number: 1851-0830S.
- Recall number
- Z-1940-2025
- Recalling firm
- Stryker GmbH
- Product
- Femoral Nail, RIGHT T2 GTN 8x300 mm. Catalog Number: 1851-0830S.
- Status
- Open, Classified
- Initiated
- 2025-05-22
- Posted
- 2025-06-10
- Terminated
- not on file
- Reason
- 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
- 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
- 2
- Distribution
- Worldwide - US Nationwide distribution in the states of California and Missouri. The countries of Belgium, Japan, Netherlands.
- Lot, serial or model codes
- Catalog Number: 1851-0830S. GTIN: 04546540647184. Batch lot number: K09F17F
- 510(k) numbers
- ["K101438"]
- 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