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Na 2347-22-32

by Zimmer, Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None ongoing

18 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 Number00889024052239 UDI-DI Date16 Oct 2015ListedStatusListed GUDID: in commercial distribution

Recalls

18 recalls · FDA

  • 2 recalls, same reason

    • Terminated Z-0315-2020 FDA Class II initiated 10 Oct 2019 on shared 510(k) K142579
    • Terminated Z-0307-2020 FDA Class II initiated 10 Oct 2019 on shared 510(k) K142579

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

    • Terminated Z-1684-2016 FDA Class II initiated 4 May 2016

    A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant Screws.

  • 4 recalls, same reason

    • Terminated Z-1161-2016 FDA Class II initiated 11 Jan 2016
    • Terminated Z-1115-2016 FDA Class II initiated 11 Jan 2016
    • Terminated Z-1145-2016 FDA Class II initiated 11 Jan 2016
    • Terminated Z-1123-2016 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-0875-2015 FDA Class II initiated 4 Dec 2014

    Zimmer received a single complaint wherein a Trilogy® Fiber Metal Multi-Hole Acetabular Shell would not attach to the inserter/impactor instrumentation. Subsequent investigation found the polar-hole threads to be present but non-conforming to specifications, in that the minor diameter was undersized. Investigation also indicates that the issue is isolated and affects only lot 62714305, which

    • Terminated Z-0824-2015 FDA Class II initiated 21 Nov 2014

    Analysis of returned complaint devices, product in inventory, and device manufacturing records has identified tool marks isolated to one specific machining mill to be the cause of the fractures. .

    • Terminated Z-2032-2014 FDA Class II initiated 12 Jun 2014

    Two lots of screws were commingled. Screws with etching and machining for lot number 62629432 were packaged in bags labeled for lot number 62628759; and screws with etching and machining for lot number 62628759 were packaged in bags labeled for lot number 62629432. The affected product was distributed between 3/6/14 and 4/21/14.

    • Terminated Z-1024-2014 FDA Class II initiated 11 Oct 2013

    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.

  • 5 recalls, same reason

    • Terminated Z-0773-2013 FDA Class II initiated 14 Sep 2012
    • Terminated Z-0772-2013 FDA Class II initiated 14 Sep 2012
    • Terminated Z-0771-2013 FDA Class II initiated 14 Sep 2012
    • Terminated Z-0769-2013 FDA Class II initiated 14 Sep 2012
    • Terminated Z-0775-2013 FDA Class II initiated 14 Sep 2012

    Some units of Trilogy shells manufactured since March 2009 may be below the lower range of the pore size specification (as low as 28% vs. 30% porosity specification). On 10/31/2012, the firm expanded the recall action to include lots of Uni-Hole Trilogy Acetabular System shells.

    • Terminated Z-0620-2008 FDA Unclassified (pre-2012) initiated 19 Oct 2007

    Parts missing and incomplete etch: The units may not contain the locking ring or the etched alignment marks on the rim.

    • Terminated Z-1344-06 FDA Unclassified (pre-2012) initiated 26 Jun 2006

    Lack of assurance of sterility, as the sterile barrier packaging may have been compromised.

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

Generic Name
Orthopaedic bone screw (non-sliding)
Model / Ref / Catalog
2347-22-32, 00-2347-022-32
Primary DI / UDI-DI
00889024052239
510(k) Number
FDA Product Code
LPH, HWC
GMDN Term
Orthopaedic bone screw (non-sliding)
Device Class
Class II
Regulation Number
888.3358, 888.3040
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization
Size
Length — 32 Millimeter

Related devices

Category: Orthopaedic bone screw (non-sliding)

Cleared under the same submission (K142579)

Show all (12)

Cleared under the same submission (K934765)

Show all (12)

Other devices from Zimmer, Inc.

See all devices from Zimmer, Inc. →

Properties

  • Single Use
  • Implantable
  • Prescription Use
  • Lot / Batch Number

Other properties (10)

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