Stryker GmbH — FDA Compliance Timeline

FDA action counts

Risk pattern analysis

Argus HQ analysis — not an FDA finding

This section is Argus HQ analysis, not an FDA finding. Stryker GmbH has 7 separate FDA recalls on file, more than a single isolated recall event. A pattern across multiple FDA touchpoints does not by itself establish that any specific product currently poses a risk; it reflects only the frequency of FDA engagement with this company as recorded in Argus HQ's database. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures. This page reflects only the FDA event types Argus HQ currently tracks -- FDA Warning Letters, recalls, drug and biologic approvals, and Form 483 inspection observations -- and will update automatically as new FDA records are observed. Argus HQ does not independently verify FDA's underlying findings; this page summarizes what FDA has published and links back to the original FDA source for each event. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures.

Enforcement history

On 2025-06-18, Argus HQ recorded an FDA recall for Stryker GmbH, rated "high" severity in Argus HQ's classification: Stryker GmbH — Class II recall: Femoral Nail, LEFT T2 GTN 8x300 mm. Catalog Number: 1850-0830S.. On 2025-06-18, Argus HQ recorded an FDA recall for Stryker GmbH, rated "high" severity in Argus HQ's classification: Stryker GmbH — Class II recall: Femoral Nail, RIGHT T2 GTN 8x300 mm. Catalog Number: 1851-0830S.. On 2025-06-18, Argus HQ recorded an FDA recall for Stryker GmbH, rated "high" severity in Argus HQ's classification: Stryker GmbH — Class II recall: Long Nail, RIGHT Gamma4 10x320mm x 125, component of the Gamma4 System. Catalog…. On 2025-04-23, Argus HQ recorded an FDA recall for Stryker GmbH, rated "high" severity in Argus HQ's classification: Stryker GmbH — Class II recall: Guide Wire with Ruler Tube 3x800 mm DIA; Catalog number/REF: 2351-3080S;. On 2025-04-23, Argus HQ recorded an FDA recall for Stryker GmbH, rated "high" severity in Argus HQ's classification: Stryker GmbH — Class II recall: Guide Wire with Ruler Tube 3x1000 mm DIA; Catalog number/REF: 2351-3100S;. On 2024-07-03, Argus HQ recorded an FDA recall for Stryker GmbH, rated "high" severity in Argus HQ's classification: Stryker GmbH — Class II recall: Stryker Hoffman LRF Wire Tensioner REF 4933-9-100, a component of the Hoffmann L…. On 2023-03-08, Argus HQ recorded an FDA recall for Stryker GmbH, rated "high" severity in Argus HQ's classification: Stryker GmbH — Class II recall: stryker Hoffmann LRF, Transport Strut, Model Number 4933-0-400; Orthopedic exter…. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures. This page reflects only the FDA event types Argus HQ currently tracks -- FDA Warning Letters, recalls, drug and biologic approvals, and Form 483 inspection observations -- and will update automatically as new FDA records are observed.

Frequently asked questions

How many FDA actions has Stryker GmbH had?

Argus HQ has recorded 7 FDA events for Stryker GmbH: 0 warning letters, 7 recalls, 0 approvals, and 0 Form 483 inspection observations. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures.

What is the most recent FDA action against Stryker GmbH?

The most recent FDA event Argus HQ has on file for Stryker GmbH is dated 2025-06-18, with a severity rating of "high" in Argus HQ's classification. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures.

Does Argus HQ track new FDA actions for Stryker GmbH automatically?

Yes. Argus HQ ingests FDA sources daily, including FDA warning letters, recalls, drug and biologic approvals, and Form 483 inspection observations. When a new FDA action linked to Stryker GmbH is observed, this page's event count and history update automatically.

How many FDA actions does Argus HQ track for Stryker GmbH?

7 total: 0 warning letters, 7 recalls, 0 approval records, and 0 Form 483 inspection citations.

Related enforcement actions

• Stryker GmbH — Class II recall: Long Nail, RIGHT Gamma4 10x320mm x 125, component of the Gamma4 System. Catalog… →
• Stryker GmbH — Class II recall: Femoral Nail, RIGHT T2 GTN 8x300 mm. Catalog Number: 1851-0830S. →
• Stryker GmbH — Class II recall: Femoral Nail, LEFT T2 GTN 8x300 mm. Catalog Number: 1850-0830S. →
• Stryker GmbH — Class II recall: Guide Wire with Ruler Tube 3x1000 mm DIA; Catalog number/REF: 2351-3100S; →
• Stryker GmbH — Class II recall: Guide Wire with Ruler Tube 3x800 mm DIA; Catalog number/REF: 2351-3080S; →
• Stryker GmbH — Class II recall: Stryker Hoffman LRF Wire Tensioner REF 4933-9-100, a component of the Hoffmann L… →
• Stryker GmbH — Class II recall: stryker Hoffmann LRF, Transport Strut, Model Number 4933-0-400; Orthopedic exter… →

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