Link MP Reconstruction Hip

• 21 recalls, same reason

  • Terminated Z-2073-2013 FDA Class II ·initiated 16 Jul 2013 ·on shared 510(k) K955296
  • Terminated Z-2064-2013 FDA Class II ·initiated 16 Jul 2013 ·on shared 510(k) K955296
  • Terminated Z-2074-2013 FDA Class II ·initiated 16 Jul 2013 ·on shared 510(k) K955296
  • Terminated Z-2061-2013 FDA Class II ·initiated 16 Jul 2013 ·on shared 510(k) K955296
  • Terminated Z-2060-2013 FDA Class II ·initiated 16 Jul 2013 ·on shared 510(k) K955296
  • Terminated Z-2065-2013 FDA Class II ·initiated 16 Jul 2013 ·on shared 510(k) K955296
  • Terminated Z-2063-2013 FDA Class II ·initiated 16 Jul 2013 ·on shared 510(k) K955296
  • Terminated Z-2079-2013 FDA Class II ·initiated 16 Jul 2013 ·on shared 510(k) K955296
  • Terminated Z-2075-2013 FDA Class II ·initiated 16 Jul 2013 ·on shared 510(k) K955296
  • Terminated Z-2062-2013 FDA Class II ·initiated 16 Jul 2013 ·on shared 510(k) K955296
  • Terminated Z-2066-2013 FDA Class II ·initiated 16 Jul 2013 ·on shared 510(k) K955296
  • Terminated Z-2069-2013 FDA Class II ·initiated 16 Jul 2013 ·on shared 510(k) K955296
  • Terminated Z-2068-2013 FDA Class II ·initiated 16 Jul 2013 ·on shared 510(k) K955296
  • Terminated Z-2080-2013 FDA Class II ·initiated 16 Jul 2013 ·on shared 510(k) K955296
  • Terminated Z-2076-2013 FDA Class II ·initiated 16 Jul 2013 ·on shared 510(k) K955296
  • Terminated Z-2078-2013 FDA Class II ·initiated 16 Jul 2013 ·on shared 510(k) K955296
  • Terminated Z-2072-2013 FDA Class II ·initiated 16 Jul 2013 ·on shared 510(k) K955296
  • Terminated Z-2071-2013 FDA Class II ·initiated 16 Jul 2013 ·on shared 510(k) K955296
  • Terminated Z-2070-2013 FDA Class II ·initiated 16 Jul 2013 ·on shared 510(k) K955296
  • Terminated Z-2077-2013 FDA Class II ·initiated 16 Jul 2013 ·on shared 510(k) K955296
  • Terminated Z-2067-2013 FDA Class II ·initiated 16 Jul 2013 ·on shared 510(k) K955296

  The trial stems were manufactured using the wrong design.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K955296 ↗

FDA Product Code

JDI

Device Class

Class II

Regulation

21 CFR Part 888.3350

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Link Cortical Screws

  Class II

  FDA 510(k) K854827 Active Cleared 27 Dec 1985

• Link Contour Ribbed Hip Prostheses System

  Class II

  FDA 510(k) K854465 Active Cleared 10 Feb 1986

• Link Ceramic Heads 12/14 X 32mm

  Class II

  FDA 510(k) K931571 Active Cleared 19 Apr 1994

• Schwabe Radius Plates

  Class II

  FDA 510(k) K914803 Active Cleared 28 Apr 1992

• Radius Osteotomy Plates

  Class II

  FDA 510(k) K914804 Active Cleared 29 Apr 1992

• Link Dynamic Staple

  Class II

  FDA 510(k) K853704 Active Cleared 21 Jan 1986

See all devices from Link America, Inc. →

• What types of patients is the Link MP Reconstruction Hip designed to help, and why is modularity important in this context?

  The Link MP Reconstruction Hip is specifically designed for patients undergoing revision hip arthroplasty, particularly those with significant bone loss. Modularity allows surgeons to customize the implant intraoperatively, adapting to complex anatomical challenges during surgery. This flexibility ensures a better fit and stability, which is critical in revision cases where bone quality and structure may be compromised.

• Is the Link MP Reconstruction Hip reusable, or is it meant for single-use only? How does this affect its use in the operating room?

  The Link MP Reconstruction Hip is sterile and intended for single-use only. This design ensures patient safety by preventing cross-contamination and maintains the implant’s integrity, as reuse could compromise sterility and structural reliability. Clinicians must adhere to single-use protocols to comply with regulatory requirements and best practices.

• What storage conditions are required to keep the Link MP Reconstruction Hip sterile and functional before surgery?

  The device must be stored under controlled conditions to preserve sterility and functionality. Since it is sterile upon packaging, it should remain unopened until use and kept in a clean, dry environment away from direct sunlight or extreme temperatures. Proper storage ensures the implant remains uncontaminated and ready for surgery.

• How do the standardized sizes of the Link MP Reconstruction Hip help surgeons during revision procedures?

  The Link MP Reconstruction Hip comes in standardized sizes to accommodate varying patient anatomies, which is particularly useful in revision surgeries where bone loss or deformity may require precise sizing. This standardization simplifies inventory management while still allowing flexibility to address different cases, reducing intraoperative adjustments and improving surgical efficiency.