Zimmer Biomet Dual Mobility Vivacit-E Bearings Recalled for Mismatched Sizes

Agency Publication Date: November 3, 2025

Summary

Zimmer, Inc. is recalling 135 units of the Zimmer Biomet Dual Mobility Vivacit-E Bearing, a component used in hip replacement surgeries. Two specific lots were packaged incorrectly: boxes labeled as Size F (44 mm) actually contain Size G (46 mm) implants, and vice versa. This packaging error was initiated by the firm to prevent surgeons from unknowingly using the wrong-sized component during surgery.

Risk

Using an incorrectly sized bearing during a hip replacement can cause the implant to fit poorly, leading to surgical delays while a replacement is found or potential medical complications if the wrong size is implanted.

What You Should Do

This recall affects Zimmer Biomet Dual Mobility Vivacit-E Highly Crosslinked Polyethylene bearings in Size F (44 mm O.D., Catalog 110031012) and Size G (46 mm O.D., Catalog 110031013).
Identify affected units by checking the catalog and lot numbers on the outer packaging: look for lot number 67160447 (Size F) or lot number 67160480 (Size G).
Stop using the recalled devices immediately and quarantine any remaining stock to ensure they are not used in surgical procedures.
Contact Zimmer Biomet or your authorized distributor to arrange for the return, replacement, or correction of the affected inventory.
Call the FDA at 1-888-463-6332 if you have additional questions regarding this medical device recall.

Your Remedy Options

Other Action

How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: Zimmer Biomet Dual Mobility Vivacit-E Highly Crosslinked Polyethylene Bearing (Size F, 44 mm O.D.)

Variants: 28 mm I.D., 44 mm O.D., Size F

Model / REF:

110031012

Lot Numbers:

67160447

UDI:

00889024572706

Quantity: 72 units; Semi-constrained hip prosthesis

Product: Zimmer Biomet Dual Mobility Vivacit-E Highly Crosslinked Polyethylene Bearing (Size G, 46 mm O.D.)

Variants: 28 mm I.D., 46 mm O.D., Size G

Model / REF:

110031013

Lot Numbers:

671604480

UDI:

00889024572713

Quantity: 63 units; Semi-constrained hip prosthesis

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 97765

Status: Active

Manufacturer: Zimmer, Inc.

Sold By: Zimmer Biomet; Medical distributors; Hospitals; Surgical centers

Manufactured In: United States

Units Affected: 2 products (72 units; 63 units)

Distributed To: Alabama, Arizona, California, Florida, Georgia, Iowa, Illinois, Kansas, Maryland, Michigan, North Carolina, Nebraska, New Mexico, New York, Ohio, Pennsylvania, Tennessee, Texas, Washington, Wisconsin

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

This recall affects Zimmer Biomet Dual Mobility Vivacit-E Highly Crosslinked Polyethylene bearings in Size F (44 mm O.D., Catalog 110031012) and Size G (46 mm O.D., Catalog 110031013).

Identify affected units by checking the catalog and lot numbers on the outer packaging: look for lot number 67160447 (Size F) or lot number 67160480 (Size G).

Stop using the recalled devices immediately and quarantine any remaining stock to ensure they are not used in surgical procedures.

Contact Zimmer Biomet or your authorized distributor to arrange for the return, replacement, or correction of the affected inventory.

Call the FDA at 1-888-463-6332 if you have additional questions regarding this medical device recall.

Affected Products

Product: Zimmer Biomet Dual Mobility Vivacit-E Highly Crosslinked Polyethylene Bearing (Size F, 44 mm O.D.)

Variants: 28 mm I.D., 44 mm O.D., Size F

Model / REF:

110031012

Lot Numbers:

67160447

UDI:

00889024572706

Quantity: 72 units; Semi-constrained hip prosthesis

Product: Zimmer Biomet Dual Mobility Vivacit-E Highly Crosslinked Polyethylene Bearing (Size G, 46 mm O.D.)

Variants: 28 mm I.D., 46 mm O.D., Size G

Model / REF:

110031013

Lot Numbers:

671604480

UDI:

00889024572713

Quantity: 63 units; Semi-constrained hip prosthesis

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 97765

Status: Active

Manufacturer: Zimmer, Inc.

Sold By: Zimmer Biomet; Medical distributors; Hospitals; Surgical centers

Manufactured In: United States

Units Affected: 2 products (72 units; 63 units)