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Prolong® NexGen® 5952-30-14

by Zimmer, Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None ongoing

67 closed

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00889024207981 UDI-DI Date17 Sep 2015ListedStatusListed GUDID: in commercial distribution

Recalls

67 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).

  • 65 recalls, same reason

    • Terminated Z-1583-2012 FDA Not yet classified initiated 24 Feb 2012
    • Terminated Z-1598-2012 FDA Not yet classified initiated 24 Feb 2012
    • Terminated Z-1574-2012 FDA Not yet classified initiated 24 Feb 2012
    • Terminated Z-1591-2012 FDA Not yet classified initiated 24 Feb 2012
    • Terminated Z-1597-2012 FDA Not yet classified initiated 24 Feb 2012
    • Terminated Z-1580-2012 FDA Not yet classified initiated 24 Feb 2012
    • Terminated Z-1584-2012 FDA Not yet classified initiated 24 Feb 2012
    • Terminated Z-1555-2012 FDA Not yet classified initiated 24 Feb 2012
    • Terminated Z-1560-2012 FDA Not yet classified initiated 24 Feb 2012
    • Terminated Z-1603-2012 FDA Not yet classified initiated 24 Feb 2012
    • Terminated Z-1589-2012 FDA Not yet classified initiated 24 Feb 2012
    • Terminated Z-1608-2012 FDA Not yet classified initiated 24 Feb 2012
    • Terminated Z-1573-2012 FDA Not yet classified initiated 24 Feb 2012
    • Terminated Z-1569-2012 FDA Not yet classified initiated 24 Feb 2012
    • Terminated Z-1565-2012 FDA Not yet classified initiated 24 Feb 2012
    • Terminated Z-1575-2012 FDA Not yet classified initiated 24 Feb 2012
    • Terminated Z-1593-2012 FDA Not yet classified initiated 24 Feb 2012
    • Terminated Z-1552-2012 FDA Not yet classified initiated 24 Feb 2012
    • Terminated Z-1561-2012 FDA Not yet classified initiated 24 Feb 2012
    • Terminated Z-1604-2012 FDA Not yet classified initiated 24 Feb 2012
    • Terminated Z-1581-2012 FDA Not yet classified initiated 24 Feb 2012
    • Terminated Z-1576-2012 FDA Not yet classified initiated 24 Feb 2012
    • Terminated Z-1550-2012 FDA Not yet classified initiated 24 Feb 2012
    • Terminated Z-1556-2012 FDA Not yet classified initiated 24 Feb 2012
    • Terminated Z-1559-2012 FDA Not yet classified initiated 24 Feb 2012
    • Terminated Z-1587-2012 FDA Not yet classified initiated 24 Feb 2012
    • Terminated Z-1562-2012 FDA Not yet classified initiated 24 Feb 2012
    • Terminated Z-1602-2012 FDA Not yet classified initiated 24 Feb 2012
    • Terminated Z-1601-2012 FDA Not yet classified initiated 24 Feb 2012
    • Terminated Z-1578-2012 FDA Not yet classified initiated 24 Feb 2012
    • Terminated Z-1563-2012 FDA Not yet classified initiated 24 Feb 2012
    • Terminated Z-1592-2012 FDA Not yet classified initiated 24 Feb 2012
    • Terminated Z-1609-2012 FDA Not yet classified initiated 24 Feb 2012
    • Terminated Z-1564-2012 FDA Not yet classified initiated 24 Feb 2012
    • Terminated Z-1605-2012 FDA Not yet classified initiated 24 Feb 2012
    • Terminated Z-1582-2012 FDA Not yet classified initiated 24 Feb 2012
    • Terminated Z-1590-2012 FDA Not yet classified initiated 24 Feb 2012
    • Terminated Z-1599-2012 FDA Not yet classified initiated 24 Feb 2012
    • Terminated Z-1586-2012 FDA Not yet classified initiated 24 Feb 2012
    • Terminated Z-1611-2012 FDA Not yet classified initiated 24 Feb 2012
    • Terminated Z-1547-2012 FDA Not yet classified initiated 24 Feb 2012
    • Terminated Z-1551-2012 FDA Not yet classified initiated 24 Feb 2012
    • Terminated Z-1549-2012 FDA Not yet classified initiated 24 Feb 2012
    • Terminated Z-1594-2012 FDA Not yet classified initiated 24 Feb 2012
    • Terminated Z-1577-2012 FDA Not yet classified initiated 24 Feb 2012
    • Terminated Z-1610-2012 FDA Not yet classified initiated 24 Feb 2012
    • Terminated Z-1567-2012 FDA Not yet classified initiated 24 Feb 2012
    • Terminated Z-1607-2012 FDA Not yet classified initiated 24 Feb 2012
    • Terminated Z-1595-2012 FDA Not yet classified initiated 24 Feb 2012
    • Terminated Z-1600-2012 FDA Not yet classified initiated 24 Feb 2012
    • Terminated Z-1579-2012 FDA Not yet classified initiated 24 Feb 2012
    • Terminated Z-1588-2012 FDA Not yet classified initiated 24 Feb 2012
    • Terminated Z-1548-2012 FDA Not yet classified initiated 24 Feb 2012
    • Terminated Z-1557-2012 FDA Not yet classified initiated 24 Feb 2012
    • Terminated Z-1554-2012 FDA Not yet classified initiated 24 Feb 2012
    • Terminated Z-1596-2012 FDA Not yet classified initiated 24 Feb 2012
    • Terminated Z-1566-2012 FDA Not yet classified initiated 24 Feb 2012
    • Terminated Z-1570-2012 FDA Not yet classified initiated 24 Feb 2012
    • Terminated Z-1553-2012 FDA Not yet classified initiated 24 Feb 2012
    • Terminated Z-1568-2012 FDA Not yet classified initiated 24 Feb 2012
    • Terminated Z-1585-2012 FDA Not yet classified initiated 24 Feb 2012
    • Terminated Z-1558-2012 FDA Not yet classified initiated 24 Feb 2012
    • Terminated Z-1572-2012 FDA Not yet classified initiated 24 Feb 2012
    • Terminated Z-1606-2012 FDA Not yet classified initiated 24 Feb 2012
    • Terminated Z-1571-2012 FDA Not yet classified initiated 24 Feb 2012

    Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur, even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation identified additional instances where a CR micro articular surface and standard CR femur were sold together on the same purchase order. CR micro articular surfaces are

Coverage

1 jurisdiction

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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Prolong® NexGen®
Generic Name
Tibial insert
Model / Ref / Catalog
5952-30-14, 00-5952-030-14
Primary DI / UDI-DI
00889024207981
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 — 14 Millimeter

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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