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Na 47-2357-004-16

by Zimmer, Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None ongoing

5 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 Number00889024088122 UDI-DI Date28 Sep 2017ListedStatusListed GUDID: in commercial distribution

Recalls

5 recalls · FDA

  • 4 recalls, same reason

    • Terminated Z-0316-2020 FDA Class II initiated 10 Oct 2019
    • Terminated Z-0311-2020 FDA Class II initiated 10 Oct 2019
    • Terminated Z-0309-2020 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).

    • Terminated Z-0646-2016 FDA Class II initiated 9 Dec 2015

    Product on the package label did not match what was inside the package. The label was for part number 00-2359-058-35 (Zimmer Periarticular Locking Plate System 3.5mm Locking Screw 58mm Length) lot number 62918019 while the product inside the package was part number 00-2359-014-24 (Zimmer Periarticular Locking Plate System 2.4mm Locking Screw 14mm Length) lot number 62896038.

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  • Withdrawn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
47-2357-004-16
Primary DI / UDI-DI
00889024088122
510(k) Number
FDA Product Code
HWC, HRS
GMDN Term
Orthopaedic fixation plate, non-bioabsorbable
Device Class
Class II
Regulation Number
888.3040, 888.3030
GUDID distribution status
In Commercial Distribution
Size
Length — 224 Millimeter

Related devices

Category: Orthopaedic fixation plate, non-bioabsorbable

Cleared under the same submission (K042598)

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Cleared under the same submission (K111039)

Show all (12)

Other devices from Zimmer, Inc.

See all devices from Zimmer, Inc. →

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