What is the most recent FDA action on file for Stryker Spine?

April 9, 2025. Argus HQ ingests new FDA enforcement records daily.

Has Stryker Spine had product recalls?

Yes, 6 recalls on file. See the full history below for each one.

Is this FDA enforcement data for Stryker Spine official?

Every record links directly to its primary FDA.gov source. Argus HQ aggregates and structures public FDA data; the verbatim FDA record is always the source of truth.

How many FDA actions has Stryker Spine had?

Argus HQ has recorded 6 FDA events for Stryker Spine: 0 warning letters, 6 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.

Stryker Spine — FDA Enforcement History

FDA action counts

Total FDA actions	6
Warning letters	0
Recalls	6
Approval records	0
Form 483 inspection citations	0
Most recent action	April 9, 2025

Key takeaway: Argus HQ has recorded 6 FDA events for Stryker Spine: 0 warning letters, 6 recalls, 0 approvals, and 0 inspection 483 observations. These events span from 2023-12-27 to 2025-04-09. The most severe rating Argus HQ has assigned across this history is "high". 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 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.

Risk pattern analysis

Argus HQ analysis — not an FDA finding

This section is Argus HQ analysis, not an FDA finding. Stryker Spine has 6 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 2025-04-09, Argus HQ recorded an FDA recall for Stryker Spine, rated "high" severity in Argus HQ's classification: Stryker Spine — Class II recall: Monterey AL Implant Inserter; 14/16mm; Catalog 48019120.. On 2025-04-09, Argus HQ recorded an FDA recall for Stryker Spine, rated "high" severity in Argus HQ's classification: Stryker Spine — Class II recall: Monterey AL Implant Inserter; 10/12mm; Catalog 48019100.. On 2025-04-09, Argus HQ recorded an FDA recall for Stryker Spine, rated "high" severity in Argus HQ's classification: Stryker Spine — Class II recall: Monterey AL Implant Inserter; 18/20mm; Catalog 48019130.. On 2025-04-09, Argus HQ recorded an FDA recall for Stryker Spine, rated "high" severity in Argus HQ's classification: Stryker Spine — Class II recall: Monterey AL Implant Inserter; 22mm; Catalog 48019140.. On 2024-10-02, Argus HQ recorded an FDA recall for Stryker Spine, rated "high" severity in Argus HQ's classification: Stryker Spine — Class II recall: AVS Anchor-C Cervical Cage System Instructions For Use (IFU)- eIFU (revision 5)-…. On 2023-12-27, Argus HQ recorded an FDA recall for Stryker Spine, rated "high" severity in Argus HQ's classification: Stryker Spine — Class II recall: LITe Decompression Snake Arm, REF 48080230. 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 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

What is the most recent FDA action on file for Stryker Spine?: April 9, 2025. Argus HQ ingests new FDA enforcement records daily.
Has Stryker Spine had product recalls?: Yes, 6 recalls on file. See the full history below for each one.
Is this FDA enforcement data for Stryker Spine official?: Every record links directly to its primary FDA.gov source. Argus HQ aggregates and structures public FDA data; the verbatim FDA record is always the source of truth.
How many FDA actions has Stryker Spine had?: Argus HQ has recorded 6 FDA events for Stryker Spine: 0 warning letters, 6 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.

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Compiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder

Verified from FDA.gov · Last updated: Apr 9, 2025

Cite this record

Reusing this data in reporting or research? Here’s a ready-made citation.

APA

Argus HQ Research (2025). Stryker Spine — FDA Enforcement History. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/company/stryker-spine

MLA

"Stryker Spine — FDA Enforcement History." Argus HQ Research, Digital Empire Holdings LLC, 2025, argushq.ai/company/stryker-spine.

Chicago

Argus HQ Research. "Stryker Spine — FDA Enforcement History." Digital Empire Holdings LLC. Accessed July 17, 2026. https://argushq.ai/company/stryker-spine.

BibTeX

@misc{argushq_argushq_ai_company_stryker_spine_2025,
  title = {Stryker Spine — FDA Enforcement History},
  author = {{Argus HQ Research}},
  year = {2025},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/company/stryker-spine},
  note = {Accessed: July 17, 2026}
}

Source: FDA.gov (aggregated across Warning Letters, Recalls, Approvals, Form 483s) ↗