ARCOMXL Active Articulation

• 2 recalls, same reason

  • Terminated Z-1024-2017 FDA Class II ·initiated 19 Dec 2016
  • Terminated Z-1025-2017 FDA Class II ·initiated 19 Dec 2016

  Product complaints indicated that the part and lot numbers on the packaging differed from the physical product inside the packaging. Risk of delay in surgery.

510(k) Number

K110555 ↗

FDA Product Code

LPH

Device Class

Class II

Regulation

21 CFR Part 888.3358

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

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See all devices from Biomet Manufacturing Corp →

• What is the ARCOMXL Active Articulation designed for?

  The ARCOMXL Active Articulation is a semi-constrained acetabular component specifically designed for total hip arthroplasty (replacement surgery). Its active articulation mechanism improves mobility and stability, making it ideal for patients who need moderate rotational control during hip movement. The porous coating also promotes osseointegration, allowing the implant to integrate with bone over time without the need for bone cement.

• How is the ARCOMXL Active Articulation supplied and prepared for use?

  This device is supplied as a single-use, sterile component, meaning it is intended for one surgical procedure only and must remain unopened until implantation. Sterility is critical, so it must be handled according to sterile medical device protocols to maintain its integrity before use. Always follow manufacturer guidelines for unpacking and preparation to ensure proper surgical conditions.

• Is the ARCOMXL Active Articulation reusable or single-use?

  The ARCOMXL Active Articulation is explicitly designed for single-use only. This classification ensures patient safety by preventing cross-contamination and maintaining sterility. Reuse of this device is not recommended or approved, as it could compromise its structural integrity and risk infection.

• What materials are used in the construction of the ARCOMXL Active Articulation?

  The device combines metal, polymer, and additional metal components to create a durable yet flexible acetabular shell. The porous coating is applied to the metal surface to enhance osseointegration, allowing the implant to bond with the patient’s bone over time. This design balances stability with the natural movement of the hip joint.

• How should the ARCOMXL Active Articulation be stored before use?

  Storage must adhere to strict sterile medical device protocols to preserve the device’s integrity. It should be kept in its original, unopened packaging in a clean, dry environment away from direct sunlight or extreme temperatures. Follow the manufacturer’s instructions for storage duration and conditions to ensure the device remains sterile and functional until surgery.