Lower risk Medical device recall · FDA · Published March 24, 2025

Zimmer Biomet Hip Prosthesis Recall: Incompatible Ceramic Heads Risk Injury

Zimmer Biomet recalls ceramic hip prostheses with 22.2mm diameter heads that may not fit with certain stems, risking improper fit and injury. Affected units include specific model numbers and lots.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1648-2025Medical device Zimmer ›

Lower-risk recall

The associated product labeling does not adequately provide compatibility information for use of the 22.2 mm Diameter Ceramic Femoral Heads with cobalt-chrome femoral stems or stainless-steel femoral stems.

Take action

Contact the company

Recalling firmZimmer, Inc.1800 W Center St · Warsaw, IN 46580-2304

✎ GovInfoNow plain-language explainer

Zimmer Biomet is recalling hip prostheses with 22.2 mm ceramic heads that may not be compatible with cobalt-chrome or stainless-steel femoral stems. This could lead to improper fit and potential injury during surgery or long-term use. Read more at govinfonow.com/recall/52541-zimmer-biomet-hip-prosthesis-recall-incompatible-ceramic-heads-risk-injury.

Source Summary by GovInfoNow · govinfonow.com/recall/52541-zimmer-biomet-hip-prosthesis-recall-incompatible-ceramic-heads-risk-injury · Updated August 18, 2026 · FDA enforcement record: FDA #Z-1648-2025

Cite this page

“Zimmer Biomet Hip Prosthesis Recall: Incompatible Ceramic Heads Risk Injury.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/52541-zimmer-biomet-hip-prosthesis-recall-incompatible-ceramic-heads-risk-injury. Based on FDA recall #Z-1648-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1648-2025%22&limit=1).

Zimmer, Inc. recalled Zimmer Biomet Ceramic Hip Prosthesis components due to inadequate labeling regarding compatibility with certain femoral stems, the FDA said on March 24, 2025. The recall affects 158 units distributed worldwide.

How to tell if you have it

Brand: Zimmer
Product: Zimmer Biomet Ceramic Head, 22.2 mm Diameter, Type 1, +0 Neck; Prosthesis, Hip
Model Number: 802802202
UPC: 00887868376351
Lot Codes: IFU 87-6204-051-99 Rev D or prior

The hazard

The product labeling does not adequately provide compatibility information for use of the 22.2 mm Diameter Ceramic Femoral Heads with cobalt-chrome femoral stems or stainless-steel femoral stems, according to the FDA.

Context

GovInfoNow's records show Zimmer, Inc. has 19 other recalls on record since August 25, 2022. Recent brand recalls include a May 20, 2026 recall of an Off-Axis Alliance Glenoid Reamer Guide due to breakage risk and a March 30, 2026 recall of Disposable Mixing Bowls with Spatula due to package seal issues. Other recent recalls of similar products include Howmedica Osteonics Recalls Hip Implant Components Due to Oxidation Risk (July 30, 2026) and Howmedica OMNIFIT Series I Acetabular Insert Recall: Oxidation Risk (July 30, 2026).

How to tell if you have this one

Check for the model number 802802202 on the ceramic head. The prosthesis was sold with specific IFU (instruction for use) versions 87-6204-051-99 Rev D or earlier. It was distributed with GTIN 00887868376351.

Brand
Zimmer
Product
Zimmer Biomet Ceramic Head, 22.2 mm Diameter, Type 1, +0 Neck, Model Number 802802202; Prosthesis, Hip
Category
Medical device

FDA recall event · 5 products

All 5 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Ongoing
Distribution
Worldwide distribution - US Nationwide and the countries of Panama, Hong Kong, China.

Recall number	Product, codes & lots	Quantity
Z-1645-2025	Zimmer Biomet Ceramic Head, 22.2 mm Diameter, 12/14 Taper, +0 Neck, Model Number 802602202; Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented or Non- Porous, Uncemented; GTIN 00887868376320, All lots distributed with IFU 87-6204-051-99 Rev D or prior	416 units
Z-1646-2025	Zimmer Biomet Ceramic Head, 22.2 mm Diameter, 12/14 Taper, +3 Neck, Model Number 802602203; Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented or Non- Porous, Uncemented; GTIN 00887868376337, All lots distributed with IFU 87-6204-051-99 Rev D or prior	215 units
Z-1647-2025	Zimmer Biomet Ceramic Head, 22.2 mm Diameter, Type 1, -3 Neck, Model Number 802802201; Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented or Non- Porous, Uncemented; GTIN 00887868376344, All lots distributed with IFU 87-6204-051-99 Rev D or prior	167 units
Z-1648-2025	Zimmer Biomet Ceramic Head, 22.2 mm Diameter, Type 1, +0 Neck, Model Number 802802202; Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented or Non- Porous, Uncemented; GTIN 00887868376351, All lots distributed with IFU 87-6204-051-99 Rev D or prior	158 units
Z-1649-2025	Zimmer Biomet Ceramic Head, 22.2 mm Diameter, Type 1, +3 Neck, Model Number 802802203; Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented or Non- Porous, Uncemented; GTIN 00887868376368, All lots distributed with IFU 87-6204-051-99 Rev D or prior	160 units

Based on the official FDA remedy

What to do — step by step

Check Prosthesis Model
Verify the model number on the ceramic head is 802802202.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

FDA distribution: “Worldwide distribution - US Nationwide and the countries of Panama, Hong Kong, China.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

FDA published this recall 37 days after the firm started it.

Mar 24, 2025Firm started the recall
Apr 21, 2025FDA classified it Class II
Apr 30, 2025Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/52541-zimmer-biomet-hip-prosthesis-recall-incompatible-ceramic-heads-risk-injury">Zimmer Biomet Hip Prosthesis Recall: Incompatible Ceramic Heads Risk Injury (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-1648-2025 (March 24, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1648-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.