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Na 00-2358-008-05

by Zimmer, Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

1 ongoing

This device is named in the recall

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 Number00889024056282 UDI-DI Date16 Oct 2015ListedStatusListed GUDID: in commercial distribution

Recalls

9 recalls · 1 ongoing · FDA

    • Ongoing Z-2254-2023 FDA Class II initiated 27 Jun 2023

    Thread form issue of the locking holes in that the locking screws would not properly mate with the plate. The improperly mated screw may not be readily recognizable by the user since the screw may not correctly lock.

  • 2 recalls, same reason

    • Terminated Z-0317-2020 FDA Class II initiated 10 Oct 2019
    • Terminated Z-0310-2020 FDA Class II initiated 10 Oct 2019

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

  • 5 recalls, same reason

    • Terminated Z-0588-2014 FDA Class II initiated 5 Nov 2013
    • Terminated Z-0591-2014 FDA Class II initiated 5 Nov 2013
    • Terminated Z-0585-2014 FDA Class II initiated 5 Nov 2013
    • Terminated Z-0589-2014 FDA Class II initiated 5 Nov 2013 on shared 510(k) K082078
    • Terminated Z-0587-2014 FDA Class II initiated 5 Nov 2013 on shared 510(k) K082078

    Based on a review of historic packaging validations, it was determined that a subset of product packaged at a Zimmer facility required testing to ensure that previously packaged product from this facility met the established requirements for sterile barrier integrity. This testing determined that a packaging tray configuration which consists of an inner and outer sterile tray, resulted in failure

    • Terminated Z-2101-2013 FDA Class II initiated 30 Jul 2013

    Zimmer is initiating a lot specific voluntary recall of the Distal Medial Humeral Locking Plate, Short due to the incorrect information printed on the Chinese label. The original label indicates that implants are RIGHT sided, but the Chinese label indicates that the implants are LEFT sided.

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 fixation plate, non-bioabsorbable
Model / Ref / Catalog
00-2358-008-05
Primary DI / UDI-DI
00889024056282
510(k) Number
FDA Product Code
HRS
GMDN Term
Orthopaedic fixation plate, non-bioabsorbable
Device Class
Class II
Regulation Number
888.3030
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization
Size
Length — 104 Millimeter

Related devices

Category: Orthopaedic fixation plate, non-bioabsorbable, non-sterile

Cleared under the same submission (K082078)

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Cleared under the same submission (K141734)

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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