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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Implants & Prosthetics

Zimmer, Inc.: CPT Hip Joint Prosthesis Recalled for Risk of Femoral Fracture

Agency Publication Date: July 30, 2024
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Summary

Zimmer, Inc. has recalled approximately 247,500 units of the CPT Hip Joint Metal/Polymer Semi-Constrained Cemented Prosthesis worldwide, including 5,500 units in the United States. This recall was initiated because the product carries an increased risk of postoperative periprosthetic femoral fracture (PFF), which is a broken thigh bone that occurs around the hip implant after surgery. The company is updating the Instructions for Use (IFU) to reflect this risk. These implants are used in hip arthroplasty procedures and were distributed across the United States and internationally.

Risk

The affected hip implants have been found to have a higher likelihood of causing the thigh bone to fracture after the surgery is completed. These fractures can lead to severe pain, loss of mobility, and may require additional complex revision surgeries to repair the bone and replace the implant.

What You Should Do

  1. Identify if you have a CPT Hip Joint Metal/Polymer Semi-Constrained Cemented Prosthesis by checking your surgical records or medical device identification card for Item Numbers such as 00811400000, 00811400218, 00811400420, or any of the other 25 specific codes listed in the recall.
  2. If you are unsure which hip implant was used during your surgery, contact your orthopedic surgeon or the medical facility where the hip arthroplasty was performed to confirm the model and item number.
  3. Contact your healthcare provider immediately if you experience new or worsening hip pain, difficulty walking, or a sensation of instability in your hip joint.
  4. Patients and healthcare providers can contact Zimmer, Inc. at their Warsaw, Indiana headquarters or through their official website for more information regarding the updated Instructions for Use and specific safety data.
  5. Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls if you have additional questions regarding medical device safety.

Your Remedy Options

๐Ÿ“‹Other Action

Information Update and Consultation

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: CPT Hip Joint Metal/Polymer Semi-Constrained Cemented Prosthesis
Model / REF:
00811400000
00811400010
00811400100
00811400110
00811400200
00811400210
00811400218
00811400230
00811400300
00811400310
00811400318
00811400330
00811400400
00811400410
00811400420
00811400423
00811400426
00811400430
00811400500
00811400510
00811400530
00811401218
00811401318
00811404000
00811405000
UPC Codes:
00889024145733
00889024145740
00889024145757
00889024145764
00889024145771
00889024145788
00889024145795
00889024145801
00889024145818
00889024145825
00889024145832
00889024145849
00889024145856
00889024145863
00889024145870
00889024145887
00889024145894
00889024145900
00889024145917
00889024145924
00889024145931
00889024145948
00889024145955
00889024145962
00889024145979

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94923
Status: Active
Manufacturer: Zimmer, Inc.
Sold By: Hospitals; Surgical Centers; Medical Device Distributors
Manufactured In: United States
Units Affected: 5,500 (US); 242,000 (OUS)
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.