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NexGen® Legacy® 5964-30-17

by Zimmer, Inc. 2 variants

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None ongoing

9 closed

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00889024634817 UDI-DI Date25 Feb 2022ListedStatusListed GUDID: in commercial distribution

Recalls

9 recalls · FDA

    • Terminated Z-2092-2023 FDA Class II initiated 19 May 2023

    Device outer packaging was incorrectly labeled.

    • Terminated Z-0321-2020 FDA Class II initiated 10 Oct 2019

    Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).

  • 3 recalls, same reason

    • Terminated Z-1045-2018 FDA Class II initiated 29 Nov 2017 on shared 510(k) K991581
    • Terminated Z-1044-2018 FDA Class II initiated 29 Nov 2017 on shared 510(k) K991581
    • Terminated Z-1043-2018 FDA Class II initiated 29 Nov 2017 on shared 510(k) K991581

    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.

    • Terminated Z-1152-2016 FDA Class II initiated 11 Jan 2016

    As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.

    • Terminated Z-0832-2016 FDA Class II initiated 11 Jan 2016

    LDPE bag containing the implant adheres to the highly polished implant surface.

    • Terminated Z-1023-2014 FDA Class II initiated 11 Oct 2013 on shared 510(k) K991581

    Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that the packaging operations conducted in the Building 1 packaging operation at this facility were not properly validated. As a result, Zimmer conducted seal integrity testing to evaluate if previously packaged product from this facility met the established requirements for sterile barrier integrity. The acceptance criteria established for this testing was 99% reliability with a 90% confidence interval. These packaging tray configurations met the acceptance criteria for sterile barrier integrity of both the inner and outer trays, however, Zimmer has decided to recall all manufacturing lots that have not expired and that were sterile packaged in the ZMBV facility Building 1 packaging operations.

    • Terminated Z-0609-2011 FDA Unclassified (pre-2012) initiated 16 Apr 2010 on shared 510(k) K991581

    The impactor may disassemble or detach during use. The detached piece may not be observed intraoperatively and may be left in the surgical site. Complications may include pain, infection, and prolongation in surgery. These complications may also require revision 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 — GUDID listing Listed

Specification

GUDID

Trade Name
NexGen® Legacy®
Generic Name
Tibial insert
Model / Ref / Catalog
5964-30-17, 00-5964-030-17
Primary DI / UDI-DI
00889024634817
510(k) Number
FDA Product Code
JWH
GMDN Term
Tibial insert
Device Class
Class II
Regulation Number
888.3560
GUDID distribution status
In Commercial Distribution
Size
Height — 17.00 Millimeter

Related devices

Category: Tibial insert

Cleared under the same submission (K173057)

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Cleared under the same submission (K991581)

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Other devices from Zimmer, Inc.

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Properties

  • Sterile
  • Single Use
  • Implantable
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (8)

  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No