Zimmer Biomet Ceramic Heads

• 5 recalls, same reason

  • Ongoing Z-1645-2025 FDA Class II ·initiated 24 Mar 2025
  • Ongoing Z-1648-2025 FDA Class II ·initiated 24 Mar 2025
  • Ongoing Z-1649-2025 FDA Class II ·initiated 24 Mar 2025
  • Ongoing Z-1647-2025 FDA Class II ·initiated 24 Mar 2025
  • Ongoing Z-1646-2025 FDA Class II ·initiated 24 Mar 2025

  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.

510(k) Number

K181171 ↗

FDA Product Code

LZO

Device Class

Class II

Regulation

21 CFR Part 888.3353

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• IDENTITY Humeral 120001790

  Class I

  GUDID on market

• IDENTITY Humeral 120001792

  Class I

  GUDID on market

• IDENTITY Humeral 120001791

  Class I

  GUDID on market

• IDENTITY Humeral 120001795

  Class I

  GUDID on market

• IDENTITY Humeral 120001793

  Class I

  GUDID on market

• Comprehensive Humeral 120001798

  Class I

  GUDID on market

See all devices from Zimmer, Inc. →

• Are these ceramic heads reusable in the operating room, or are they meant for single-use only?

  These Zimmer Biomet Ceramic Heads are explicitly designed for single-use only in sterile conditions. The manufacturer emphasizes handling them according to their guidelines to ensure proper implantation, which implies they are not intended for reprocessing or reuse. This aligns with common orthopedic best practices for ceramic components to maintain sterility and integrity during surgery.

• What types of hip procedures can these ceramic heads be used for, and how do they differ from standard metal heads?

  These ceramic heads are intended for total hip or hemi-hip arthroplasty, including both primary and revision surgeries. Unlike traditional metal femoral heads, they are made from a composite ceramic material (75% alumina and 25% zirconia), which provides enhanced durability, reduced wear, and improved biocompatibility. This composition helps restore hip function while minimizing risks like metal ion release or corrosion, which can occur with metal implants.

• What bore options are available for these ceramic heads, and how does that affect compatibility with other components?

  The Zimmer Biomet Ceramic Heads are supplied with two bore options: a 12/14 bore or a Type 1 bore. The bore size determines how the head fits onto the femoral stem or neck, ensuring proper alignment and stability during implantation. The 12/14 bore is a tapered fit, while the Type 1 bore is a standard Morse taper, so compatibility depends on the specific femoral component being used in the procedure.

• How should these ceramic heads be stored to maintain their sterility and performance before surgery?

  Since these ceramic heads are sterile and single-use, they must be stored in their original packaging until use to preserve sterility. The manufacturer’s guidelines (not detailed here) likely specify conditions like temperature control, protection from contamination, and avoiding exposure to moisture or direct sunlight. Always follow the included instructions to ensure the device remains intact and ready for surgical use.

• What regulatory pathway was followed for these ceramic heads, and what does that mean for clinicians?

  These ceramic heads received FDA 510(k) clearance (K181171) under the Traditional review pathway, with a decision code of SESE (Substantially Equivalent in Safety and Effectiveness) to a predicate device. This means the FDA determined they meet the same performance standards as an existing approved device, ensuring they comply with orthopedic safety and efficacy requirements. Clinicians can rely on this clearance as part of their due diligence when selecting components for hip arthroplasty.