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Nexgen Porous, Uncemented Femoral and Tibial Baseplate Components

by Zimmer, Inc.

510(k) K031061

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

Recall on shared 510(k) K031061; other models may be affected

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK031061 Date9 Oct 2003ClearedStatusActive

Recalls

24 recalls · 1 ongoing · FDA

    • Ongoing Z-1608-2024 FDA Class II initiated 28 Mar 2024 on shared 510(k) K031061

    Out of specification violation of devices that results in a gap existing within the fixture that presses the fiber metal pad to the substrate, causing the pad to not fully bond to the substrate.

  • 6 recalls, same reason

    • Terminated Z-1038-2018 FDA Class II initiated 29 Nov 2017 on shared 510(k) K031061
    • Terminated Z-1040-2018 FDA Class II initiated 29 Nov 2017 on shared 510(k) K031061
    • Terminated Z-1030-2018 FDA Class II initiated 29 Nov 2017
    • Terminated Z-1039-2018 FDA Class II initiated 29 Nov 2017
    • Terminated Z-1048-2018 FDA Class II initiated 29 Nov 2017
    • Terminated Z-1041-2018 FDA Class II initiated 29 Nov 2017 on shared 510(k) K031061

    The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag.

  • 2 recalls, same reason

    • Terminated Z-2092-2012 FDA Class II initiated 30 Apr 2012
    • Terminated Z-2091-2012 FDA Class II initiated 30 Apr 2012

    The design of the spring clip for the jaw assembly was updated in March 2011 due to fractures of the spring clip. Zimmer has received complaints for the spring clip fracturing on the updated design. The spring clip may fracture or fall off of the instrument during use, and a device fragment may be left in the surgical site. The risk of disassembly or fracture occurs when the instrument is typicall

  • 2 recalls, same reason

    • Terminated Z-2174-2011 FDA Unclassified (pre-2012) initiated 14 Mar 2011
    • Terminated Z-2173-2011 FDA Unclassified (pre-2012) initiated 14 Mar 2011

    The firm is initiating a recall due to the potiential for the spring clip to break off during use and fall into the surgical site. The firm has received 24 complaints of the spring breaking, four of which were reported that the patient had to undergo additional x-rays to ensure the fractured clip had not been left in-vivo.

  • 13 recalls, same reason

    • Terminated Z-1995-2011 FDA Unclassified (pre-2012) initiated 14 Mar 2011
    • Terminated Z-1985-2011 FDA Unclassified (pre-2012) initiated 14 Mar 2011
    • Terminated Z-1993-2011 FDA Unclassified (pre-2012) initiated 14 Mar 2011
    • Terminated Z-1986-2011 FDA Unclassified (pre-2012) initiated 14 Mar 2011
    • Terminated Z-1991-2011 FDA Unclassified (pre-2012) initiated 14 Mar 2011
    • Terminated Z-1992-2011 FDA Unclassified (pre-2012) initiated 14 Mar 2011
    • Terminated Z-1994-2011 FDA Unclassified (pre-2012) initiated 14 Mar 2011
    • Terminated Z-1988-2011 FDA Unclassified (pre-2012) initiated 14 Mar 2011
    • Terminated Z-1987-2011 FDA Unclassified (pre-2012) initiated 14 Mar 2011
    • Terminated Z-1996-2011 FDA Unclassified (pre-2012) initiated 14 Mar 2011
    • Terminated Z-1997-2011 FDA Unclassified (pre-2012) initiated 14 Mar 2011
    • Terminated Z-1989-2011 FDA Unclassified (pre-2012) initiated 14 Mar 2011
    • Terminated Z-1990-2011 FDA Unclassified (pre-2012) initiated 14 Mar 2011

    The firm is initiating a recall due to the potential for breakdown of the AlTiN PVD (black) coating during surgery and the coating could fall into the surgical site. The firm has received 22 reports of the black coating coming off the instruments after cleaning and sterilization cycles and 5 resulted in a delay of surgery.

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

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
MBH
Device Class
Class II
Regulation
21 CFR Part 888.3565
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

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