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Nucleus Z327685

by Cochlear

Nucleus Z327685 is a Class III device made by Cochlear, approved under FDA PMA P970051 on 25 Jun 1998 and listed in FDA GUDID since 24 Sep 2014 (UDI-DI 09321502022286), active as of 23 Oct 2026. 3 FDA recalls are linked to it.

Active United States. Also listed in GUDID (US).

PMA

Valid until

No expiry

PMA approval is not time-limited

FDA recalls

None ongoing

3 closed

Documents

PMA P970051

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 Number09321502022286 UDI-DI Date24 Sep 2014ListedStatusListed GUDID: in commercial distribution
United StatesFDA PMAAPPR from GUDID Approved NumberP970051 Date25 Jun 1998DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA PMA P970051 decided 25 Jun 1998 Active
  • FDA GUDID UDI-DI 09321502022286 listed 24 Sep 2014 Listed

Recalls

3 recalls · FDA

    • Terminated Z-2155-2015 FDA Class II initiated 5 Jun 2015

    Cochlear Americas is recalling Nucleus Sterile Silicone Template CI24RE/CI422 part number Z421736 because expired product was distributed.

    • Terminated Z-0003-2012 FDA Unclassified (pre-2012) initiated 16 Sep 2011

    Cochlear implant may shut down and cease to function.

    • Terminated Z-0119-2010 FDA Unclassified (pre-2012) initiated 30 Sep 2009

    Cochlear implant device component was mis-labeled.

Timeline

5 dated events

  1. Approved FDA PMA P970051
  2. Recall initiated FDA recalls Z-0119-2010
  3. Recall initiated FDA recalls Z-0003-2012
  4. Listed FDA GUDID 09321502022286
  5. Recall initiated FDA recalls Z-2155-2015

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA PMA Active

Specification

GUDID

Trade name
Nucleus
Generic name
Cochlear implant/auditory brainstem implant external coil
Model / Ref / Catalog
Z327685
Primary DI / UDI-DI
09321502022286
PMA number
FDA product code
MCM
GMDN term
Cochlear implant/auditory brainstem implant external coil
Device class
Class III
GUDID distribution status
In Commercial Distribution

Related devices

Category: Cochlear implant/auditory brainstem implant coil

Cleared under the same submission (P970051)

and 8 more cleared under P970051

Similar devices

Other devices filed under FDA product code MCM (IMPLANT, COCHLEAR).

Other devices from Cochlear

See all devices from Cochlear →

Properties

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