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NexGen® 5975-40-17

by Zimmer, Inc.

NexGen® 5975-40-17 (00-5975-040-17) is a Class II device made by Zimmer, Inc., cleared under FDA 510(k) K933785 on 30 Jan 1995 and listed in FDA GUDID since 10 Aug 2016 (UDI-DI 00889024215405), active (FDA 510(k)), not in commercial distribution (GUDID) as of 23 Oct 2026. 78 FDA recalls are linked to it.

Active United States. Also listed in GUDID (US), not in commercial distribution.

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

83 closed

Documents

510(k) K933785

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00889024215405 UDI-DI Date10 Aug 2016ListedStatusListed GUDID: not in commercial distribution
United StatesFDA 510(k)SN from GUDID Traditional NumberK933785 Date30 Jan 1995DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K933785 decided 30 Jan 1995 Active
  • FDA GUDID UDI-DI 00889024215405 listed 10 Aug 2016 Listed

Recalls

83 recalls · FDA

  • 5 recalls, same reason

    • Terminated Z-1038-2018 FDA Class II initiated 29 Nov 2017 on shared 510(k) K933785
    • Terminated Z-1040-2018 FDA Class II initiated 29 Nov 2017 on shared 510(k) K933785
    • Terminated Z-1039-2018 FDA Class II initiated 29 Nov 2017 on shared 510(k) K933785
    • Terminated Z-1042-2018 FDA Class II initiated 29 Nov 2017
    • Terminated Z-1041-2018 FDA Class II initiated 29 Nov 2017

    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-2115-2017 FDA Class II initiated 28 Apr 2017

    Zimmer Biomet is conducting a lot-specific medical device field action for two lots of the NexGen Offset Stem Extension implants. Product complaints indicated that the size etched on the part and labeled on the product packaging were incorrect.

    • Terminated Z-0835-2016 FDA Class II initiated 11 Jan 2016

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

  • 3 recalls, same reason

    • Terminated Z-1159-2016 FDA Class II initiated 11 Jan 2016
    • Terminated Z-1151-2016 FDA Class II initiated 11 Jan 2016
    • Terminated Z-1147-2016 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-0590-2016 FDA Class II initiated 3 Dec 2015

    A product complaint was received stating that a carton labeled as a Precoat Stemmed Tibia Size 3 was opened for use and the contents were a non-augmented Stemmed Tibia Plate size 3.

    • Terminated Z-0449-2016 FDA Class II initiated 2 Dec 2015

    Complaints were received from Thailand reporting that there was no white paper (Tyvek) seal on the inner package of P/N:00-5980-037-01 unit from lot #62460264

    • Terminated Z-2552-2014 FDA Class II initiated 22 Jul 2014

    Zimmer is recalling sterile-packaged implants and instruments packaged in six different package configurations due to packaging design verification test failures. Specifically, multiple test samples from each of the six configurations failed simulated distribution and shipping testing when the devices either breached inner or outer package trays or seal integrity was lost.

    • Terminated Z-0480-2014 FDA Class II initiated 31 Oct 2013

    Two complaints were received in which it was reported that the stem would not lock into the tibia. Evaluation of the returned device found that the stemmed portion of the tibial plate would not hold the stem as the connection was too loose. The taper diameter was found to be oversized by .010.

    • Terminated Z-1023-2014 FDA Class II initiated 11 Oct 2013 on shared 510(k) K933785

    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.

  • 65 recalls, same reason

    • Terminated Z-1606-2012 FDA Not yet classified initiated 24 Feb 2012
    • Terminated Z-1571-2012 FDA Not yet classified initiated 24 Feb 2012
    • 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-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-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

    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

    • Terminated Z-0609-2011 FDA Unclassified (pre-2012) initiated 16 Apr 2010 on shared 510(k) K933785

    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.

  • 2 recalls, same reason

    • Terminated Z-0119-2011 FDA Unclassified (pre-2012) initiated 26 Jan 2010
    • Terminated Z-0120-2011 FDA Unclassified (pre-2012) initiated 26 Jan 2010

    Zimmer had determined that two lots of these tibial implants have incorrectly positioned or missing flange plugs that were not seated in the device upon receipt to the customer. A missing flange plug could lead to a delay of surgery or possibility of wear leading to more surgery.

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

Timeline

85 dated events

  1. Recall initiated FDA recalls Z-1159-2016
  2. Recall initiated FDA recalls Z-1151-2016
  3. Recall initiated FDA recalls Z-1147-2016
  4. Listed FDA GUDID 00889024215405
  5. Recall initiated FDA recalls Z-2115-2017
  6. Recall initiated FDA recalls Z-1038-2018
  7. Recall initiated FDA recalls Z-1040-2018
  8. Recall initiated FDA recalls Z-1039-2018
  9. Recall initiated FDA recalls Z-1042-2018
  10. Recall initiated FDA recalls Z-1041-2018

75 earlier events are in the sections above.

Coverage

1 jurisdiction

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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
NexGen®
Generic name
Knee tibia prosthesis trial, reusable
Model / Ref / Catalog
5975-40-17, 00-5975-040-17
Primary DI / UDI-DI
00889024215405
510(k) Number
FDA product code
JWH
GMDN term
Knee tibia prosthesis trial, reusable
Device class
Class II
Regulation number
888.3560
GUDID distribution status
Not in Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization
Size
Height — 17 Millimeter

Related devices

Cleared under the same submission (K933785)

and 8 more cleared under K933785

Other devices from Zimmer, Inc.

See all devices from Zimmer, Inc. →

Properties

  • Sterilise before use
  • Prescription use
  • Lot / batch number
Other properties (12, all answered No)