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Persona™ 42-5099-060-03

by Zimmer, Inc.

Ref 42-5099-060-03

Persona™ 42-5099-060-03 is a device classified as Class I in the EU and Class II in the US made by Zimmer, Inc., registered in EUDAMED on 31 Oct 2026 (Basic UDI-DI 889024JMK8), cleared under FDA 510(k) K113369 on 27 Mar 2012 and listed in FDA GUDID since 24 May 2016 (UDI-DI 00889024232693), active as of 7 Nov 2026. 39 FDA recalls are linked to it.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None ongoing

39 closed

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K113369

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number889024JMK8 Basic UDI-DI 00889024232693UDI-DIDate31 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00889024232693 UDI-DI Date24 May 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK113369 Date27 Mar 2012DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 889024JMK8 registered 31 Oct 2026 Active
  • FDA 510(k) K113369 decided 27 Mar 2012 Active
  • FDA GUDID UDI-DI 00889024232693 listed 24 May 2016 Listed

Recalls

39 recalls · FDA

  • 4 recalls, same reason

    • Terminated Z-1807-2018 FDA Class II initiated 7 Aug 2017
    • Terminated Z-1805-2018 FDA Class II initiated 7 Aug 2017
    • Terminated Z-1806-2018 FDA Class II initiated 7 Aug 2017
    • Terminated Z-1808-2018 FDA Class II initiated 7 Aug 2017

    There is a potential for intermittent cracks in the raw material batch used to produce the affected products. The cleanliness of the affected products could be compromised if cracks penetrate the surface of the instrument as a result of the raw material issue.

  • 2 recalls, same reason

    • Terminated Z-1340-2016 FDA Class II initiated 17 Mar 2016
    • Terminated Z-1341-2016 FDA Class II initiated 17 Mar 2016

    The firm received a customer complaint establishing that the product (Persona PS Articular Surfaces)information shown on the box differed by sides. One side showed P/N: 42-5114-008-18/ Lot: 62632101 and the other side showed P/N: 42-5114-005-14/ Lot: 62646580.

    • Terminated Z-1157-2016 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-1360-2015 FDA Class II initiated 10 Mar 2015

    Zimmer, Inc is voluntarily recalling 22 lots of Persona Anterior Referencing Sizer with Locking Boom, part number 42-5099-088-10. Devices are being removed from distribution due to nonconforming to print specifications.

    • Terminated Z-0853-2015 FDA Class II initiated 4 Dec 2014

    The affected lot was supplied by contract manufacturer and are potentially subject to disassociation of the magnet cover. Zimmer received one complaint indicating the magnet cover of a Persona Cemented Tibial Broach Inserter/Extractor Handle lot 62085420 was missing after broaching the tibia. Postoperative radiographs were inspected and the magnet cover was not identified. The investigation indi

    • Terminated Z-1042-2015 FDA Class II initiated 25 Nov 2014

    Potential for fracture of the tip of the product. The fractured tip is approximately 4mm x 7mm x 3.5mm in size. Retained tip may result in: pain, soft tissue irritation, soft tissue damage, or increased wear due to contact with the fractured tip; Revision surgery to remove the fractured tip

    • Terminated Z-0198-2015 FDA Class II initiated 9 Oct 2014

    Cleaning process validation failure.

    • Terminated Z-0123-2015 FDA Class II initiated 7 Oct 2014

    Affected product did not undergo heat treatment hardening step leading to the potential for deformation of the tip.

  • 6 recalls, same reason

    • Terminated Z-2575-2014 FDA Class II initiated 7 Aug 2014
    • Terminated Z-2576-2014 FDA Class II initiated 7 Aug 2014
    • Terminated Z-2580-2014 FDA Class II initiated 7 Aug 2014
    • Terminated Z-2579-2014 FDA Class II initiated 7 Aug 2014
    • Terminated Z-2578-2014 FDA Class II initiated 7 Aug 2014
    • Terminated Z-2577-2014 FDA Class II initiated 7 Aug 2014

    Reports of breakage of the Persona Knee Trial Articular Surface Provisionals (TASPs). The Persona primary knee surgical technique has been updated. This field action correction is to ensure that all distributors and users of this instrument are aware of the enhanced surgical techniques.

  • 3 recalls, same reason

    • Terminated Z-2296-2014 FDA Class II initiated 10 Jun 2013
    • Terminated Z-2299-2014 FDA Class II initiated 10 Jun 2013
    • Terminated Z-2297-2014 FDA Class II initiated 10 Jun 2013

    Zimmer had received complaints that reported breakage of the Persona Knee Trial Articular Surface Provisionals (TASPs). This is a retrospective recall which covers Zimmer's corrective actions taken earlier this year concerning the TASPs.

  • 17 recalls, same reason

    • Terminated Z-0554-2013 FDA Class II initiated 14 Nov 2012
    • Terminated Z-0544-2013 FDA Class II initiated 14 Nov 2012
    • Terminated Z-0542-2013 FDA Class II initiated 14 Nov 2012
    • Terminated Z-0539-2013 FDA Class II initiated 14 Nov 2012
    • Terminated Z-0540-2013 FDA Class II initiated 14 Nov 2012
    • Terminated Z-0552-2013 FDA Class II initiated 14 Nov 2012
    • Terminated Z-0546-2013 FDA Class II initiated 14 Nov 2012
    • Terminated Z-0555-2013 FDA Class II initiated 14 Nov 2012
    • Terminated Z-0549-2013 FDA Class II initiated 14 Nov 2012
    • Terminated Z-0547-2013 FDA Class II initiated 14 Nov 2012
    • Terminated Z-0553-2013 FDA Class II initiated 14 Nov 2012
    • Terminated Z-0541-2013 FDA Class II initiated 14 Nov 2012
    • Terminated Z-0543-2013 FDA Class II initiated 14 Nov 2012
    • Terminated Z-0551-2013 FDA Class II initiated 14 Nov 2012
    • Terminated Z-0548-2013 FDA Class II initiated 14 Nov 2012
    • Terminated Z-0545-2013 FDA Class II initiated 14 Nov 2012
    • Terminated Z-0550-2013 FDA Class II initiated 14 Nov 2012

    All lots of the Persona Cemented Tibial Drill, 5 Degree Cemented Stemmed Natural Tibia implants, and associated tools including the Tibial Drill Guide, Broach, and Sizing Plate are being removed and replaced with enhanced products and instruments to reduce risks of tibial perforation which could result in tibial bone fracture due to the stress riser created by a perforation; tibial plate loosening

    • Terminated Z-2493-2012 FDA Class II initiated 7 Sep 2012

    Zimmer is initiating a recall of the Cemented Tibial Drill for the Zimmer Persona Personalized Knee System due to three reports being received as of August 29. 2012 for tibial cortex perforation during preparation of the tibial bone. The investigation into the reports that have been received found that the perforations are occurring while using the Cemented Tibial Drill. The perforations have o

Timeline

42 dated events

  1. Recall initiated FDA recalls Z-1360-2015
  2. Recall initiated FDA recalls Z-1157-2016
  3. Recall initiated FDA recalls Z-1340-2016
  4. Recall initiated FDA recalls Z-1341-2016
  5. Listed FDA GUDID 00889024232693
  6. Recall initiated FDA recalls Z-1807-2018
  7. Recall initiated FDA recalls Z-1805-2018
  8. Recall initiated FDA recalls Z-1806-2018
  9. Recall initiated FDA recalls Z-1808-2018
  10. Registered EUDAMED 889024JMK8

32 earlier events are in the sections above.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Persona™
Generic name
Orthopaedic prosthesis implantation positioning instrument, reusable
Device name
Persona Primary PS Box Cut Guide
Model / Ref / Catalog
42-5099-060-03
Primary DI / UDI-DI
00889024232693
Basic UDI-DI
889024JMK8
Direct marketing DI
00889024232693
510(k) Number
FDA product code
JWH
EMDN code
L091199 Orthopaedic prosthetics instruments, reusable - other
GMDN term
Orthopaedic prosthesis implantation positioning instrument, reusable
Device class
Class I EUDAMED
Class II GUDID
Regulation number
888.3560
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class I
GUDID
Class II

Device class is stated on each registry's own scale: Class I in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Orthopaedic prosthesis implantation positioning instrument, reusable

Cleared under the same submission (K113369)

and 8 more cleared under K113369

Similar devices in this category

Other devices filed under ORTHOPAEDIC PROSTHETICS INSTRUMENTS, REUSABLE - OTHER.

Other devices from Zimmer, Inc.

See all devices from Zimmer, Inc. →

Properties

  • Sterilise before use
  • Reusable
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction)
  • Prescription use
  • Lot / batch number
Other properties (20, all answered No)