Biomet, Inc.: RingLoc Bi-Polar Hip Cup Recalled for Incorrect Locking Ring Assembly

Agency Publication Date: June 25, 2024

Summary

Biomet, Inc. is recalling 12 units of the RingLoc Bi-Polar Hip System Acetabular Cup (41 mm Outer Diameter) because some 41 mm outer heads were potentially assembled with an incorrect 42 mm locking ring. This manufacturing defect can lead to joint instability and may require a second surgical intervention to correct. This medical device is used in hip hemi-arthroplasty procedures and was distributed across several US states including Arizona, California, New Jersey, Pennsylvania, Texas, and Virginia, as well as in Chile.

Risk

The use of a mismatched 42 mm locking ring on a 41 mm outer head creates an improper fit within the hip joint. This misalignment can cause the artificial joint to become unstable or fail, potentially leading to pain, loss of mobility, and the need for corrective surgery.

What You Should Do

Identify if your implant is affected by checking your medical records or surgical documentation for the RingLoc Bi-Polar Hip System Acetabular Cup, 41 mm Outer Diameter, Item Number 11-165206.
Check for the following specific Lot and UDI numbers: Lot 66540443 (UDI 00880304001923), Lot 66601057 (UDI 00880304001923), Lot 66623486 (UDI 00880304001923), or Lot 66635486 (UDI 00880304001923).
If you have received this implant, contact your orthopedic surgeon or healthcare provider immediately to discuss the risks and determine if a follow-up evaluation or revision surgery is necessary.
Healthcare facilities should immediately quarantine any unused units from the affected lots and contact Biomet, Inc. for return instructions.
For further information or to arrange a potential refund or replacement, contact Biomet, Inc. at their headquarters in Warsaw, Indiana.
For additional questions or to report a problem, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

Other Action

Healthcare provider or manufacturer consultation

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

Affected Products

Product: RingLoc Bi-Polar Hip System Acetabular Cup, 41 mm Outer Diameter

Model / REF:

11-165206

Lot Numbers:

66540443

66601057

66623486

66635486

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 94742

Status: Active

Manufacturer: Biomet, Inc.

Sold By: hospitals; surgical centers

Manufactured In: United States

Units Affected: 12 units

Distributed To: Arizona, California, New Jersey, Pennsylvania, Texas, Virginia

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 · 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.

Summary

What You Should Do

Identify if your implant is affected by checking your medical records or surgical documentation for the RingLoc Bi-Polar Hip System Acetabular Cup, 41 mm Outer Diameter, Item Number 11-165206.

Check for the following specific Lot and UDI numbers: Lot 66540443 (UDI 00880304001923), Lot 66601057 (UDI 00880304001923), Lot 66623486 (UDI 00880304001923), or Lot 66635486 (UDI 00880304001923).

If you have received this implant, contact your orthopedic surgeon or healthcare provider immediately to discuss the risks and determine if a follow-up evaluation or revision surgery is necessary.

Healthcare facilities should immediately quarantine any unused units from the affected lots and contact Biomet, Inc. for return instructions.

For further information or to arrange a potential refund or replacement, contact Biomet, Inc. at their headquarters in Warsaw, Indiana.

For additional questions or to report a problem, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.