FDA Actions Against Zimmer, Inc.

FDA action counts

Risk pattern analysis

Argus HQ analysis — not an FDA finding

This section is Argus HQ analysis, not an FDA finding. Zimmer, Inc. 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.

Enforcement history

On 2026-05-06, Argus HQ recorded a FDA recall for Zimmer, Inc., rated "high" severity in Argus HQ's classification: Zimmer, Inc. — Class II recall: Brand Name: Disposable Mixing Bowls with Spatula Product Name: Mixing Bowl and… An FDA recall record reflects a firm removing or correcting a product already in distribution because it does not meet FDA requirements. On 2026-07-01, Argus HQ recorded a FDA recall for Zimmer, Inc., rated "high" severity in Argus HQ's classification: Zimmer, Inc. — Class II recall: Off-Axis Alliance Glenoid, Right, 4-Peg, Augment, Reamer Guide, Model/Catalog Nu… An FDA recall record reflects a firm removing or correcting a product already in distribution because it does not meet FDA requirements. On 2026-07-01, Argus HQ recorded a FDA recall for Zimmer, Inc., rated "high" severity in Argus HQ's classification: Zimmer, Inc. — Class II recall: Brand Name: Persona Revision Product Name: Persona Revision¿ Trabecular Metal¿… An FDA recall record reflects a firm removing or correcting a product already in distribution because it does not meet FDA requirements. On 2026-07-01, Argus HQ recorded a FDA recall for Zimmer, Inc., rated "high" severity in Argus HQ's classification: Zimmer, Inc. — Class II recall: Off-Axis Alliance Glenoid, Left, 4-Peg, Augment, Reamer Guide, Model/Catalog Num… An FDA recall record reflects a firm removing or correcting a product already in distribution because it does not meet FDA requirements. On 2026-07-01, Argus HQ recorded a FDA recall for Zimmer, Inc., rated "high" severity in Argus HQ's classification: Zimmer, Inc. — Class II recall: Off-Axis Comprehensive Shoulder System, Large, Augment, Off-Axis, Reamer Guide… An FDA recall record reflects a firm removing or correcting a product already in distribution because it does not meet FDA requirements. On 2026-07-01, Argus HQ recorded a FDA recall for Zimmer, Inc., rated "high" severity in Argus HQ's classification: Zimmer, Inc. — Class II recall: Off-Axis Comprehensive Shoulder System Small, Augment, Off-Axis, Reamer Guide, M… An FDA recall record reflects a firm removing or correcting a product already in distribution because it does not meet FDA requirements. On 2026-07-01, Argus HQ recorded a FDA recall for Zimmer, Inc., rated "high" severity in Argus HQ's classification: Zimmer, Inc. — Class II recall: Off-Axis Comprehensive Shoulder System, Medium, Augment, Off-Axis, Reamer Guide… An FDA recall record reflects a firm removing or correcting a product already in distribution because it does not meet FDA requirements. In total, Zimmer, Inc. has 7 FDA events on file with Argus HQ across the sources Argus HQ currently tracks (FDA Warning Letters, recalls, drug/biologic approvals, and Form 483 inspection observations).

Frequently asked questions

Has Zimmer, Inc. had product recalls?

Yes, 7 recalls on file. See the full history below for each one.

Is this FDA enforcement data for Zimmer, Inc. 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 Zimmer, Inc. had?

Argus HQ has recorded 7 FDA events for Zimmer, Inc.: 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 Zimmer, Inc.?

The most recent FDA event Argus HQ has on file for Zimmer, Inc. is dated 2026-07-01, 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.

Related enforcement actions

• Zimmer, Inc. — Class II recall: Off-Axis Comprehensive Shoulder System, Medium, Augment, Off-Axis, Reamer Guide… →
• Zimmer, Inc. — Class II recall: Off-Axis Comprehensive Shoulder System Small, Augment, Off-Axis, Reamer Guide, M… →
• Zimmer, Inc. — Class II recall: Off-Axis Comprehensive Shoulder System, Large, Augment, Off-Axis, Reamer Guide… →
• Zimmer, Inc. — Class II recall: Off-Axis Alliance Glenoid, Left, 4-Peg, Augment, Reamer Guide, Model/Catalog Num… →
• Zimmer, Inc. — Class II recall: Brand Name: Persona Revision Product Name: Persona Revision¿ Trabecular Metal¿… →
• Zimmer, Inc. — Class II recall: Off-Axis Alliance Glenoid, Right, 4-Peg, Augment, Reamer Guide, Model/Catalog Nu… →
• Zimmer, Inc. — Class II recall: Brand Name: Disposable Mixing Bowls with Spatula Product Name: Mixing Bowl and… →

Compare with

• Zimmer, Inc. vs Medline Industries, LP
• Zimmer, Inc. vs ARROW INTERNATIONAL, LLC
• Zimmer, Inc. vs Stryker Sustainability Solutions
• Zimmer, Inc. vs Guardian Drug Co. Inc.
• Zimmer, Inc. vs B BRAUN MEDICAL INC