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Zimmer Persona Knee System

by Zimmer, Inc.

510(k) K113369

Zimmer Persona Knee System is a Class II device made by Zimmer, Inc., cleared under FDA 510(k) K113369 on 27 Mar 2012, active as of 22 Oct 2026. 39 FDA recalls are linked to it.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

39 closed

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK113369 Date27 Mar 2012ClearedStatusActive

Official records

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

40 dated events

  1. Recall initiated FDA recalls Z-1042-2015
  2. Recall initiated FDA recalls Z-0853-2015
  3. Recall initiated FDA recalls Z-1360-2015
  4. Recall initiated FDA recalls Z-1157-2016
  5. Recall initiated FDA recalls Z-1340-2016
  6. Recall initiated FDA recalls Z-1341-2016
  7. Recall initiated FDA recalls Z-1807-2018
  8. Recall initiated FDA recalls Z-1805-2018
  9. Recall initiated FDA recalls Z-1806-2018
  10. Recall initiated FDA recalls Z-1808-2018

30 earlier events are in the sections above.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
JWH
Device class
Class II
Regulation
21 CFR Part 888.3560
Advisory committee
Orthopedic
FDA decision
SESE Substantially Equivalent

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Cited by

7 more clearances cite this device.

Source: 510k-lineage (choiben314), CC BY 4.0

Devices cleared under K113369

1,471 devices · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K113369
UDI-DISize and differences
Persona Knee System 82-0152-182-21
Zimmer, Inc.
82-0153-182-21 / 82-0152-182-2100889024486850
Single use: no
On the market
Persona Knee System 82-0156-859-30
Zimmer, Inc.
82-0156-859-30 / 82-0156-859-3000889024472679
Height 10 mm
Single use: no
On the market
Persona SSI004671
Zimmer, Inc.
SSI004671 / SSI00467100889024516359
Single use: no
On the market
Persona Total Knee System 82-0153-168-04
Zimmer, Inc.
82-0153-168-04 / 82-0153-168-0400889024471450
Single use: no
On the market
Persona Total Knee System 82-0153-168-08
Zimmer, Inc.
82-0153-168-08 / 82-0153-168-0800889024471498
Single use: no
On the market
Persona Total Knee System 82-0153-168-40
Zimmer, Inc.
82-0153-168-40 / 82-0153-168-4000889024471627
Single use: no
On the market
PERSONA® 42-5007-064-02
Zimmer, Inc.
42-5007-064-02 / 42-5007-064-0200889024229488
Single use: no
On the market
PERSONA® 42-5020-062-02
Zimmer, Inc.
42-5020-062-02 / 42-5020-062-0200889024229921
Single use: yes
On the market
PERSONA® 42-5026-056-02
Zimmer, Inc.
42-5026-056-02 / 42-5026-056-0200889024230309
Single use: yes
On the market
PERSONA® 42-5027-068-01
Zimmer, Inc.
42-5027-068-01 / 42-5027-068-0100889024595729
Single use: no
On the market
PERSONA® 42-5110-006-16
Zimmer, Inc.
42-5110-006-16 / 42-5110-006-1600889024640214
Height 16.00 mm
Single use: yes
On the market
PERSONA® 42-5112-004-10
Zimmer, Inc.
42-5112-004-10 / 42-5112-004-1000889024640542
Height 10.00 mm
Single use: yes
On the market
PERSONA® 42-5112-004-14
Zimmer, Inc.
42-5112-004-14 / 42-5112-004-1400889024640580
Height 14.00 mm
Single use: yes
On the market
PERSONA® 42-5112-006-16
Zimmer, Inc.
42-5112-006-16 / 42-5112-006-1600889024640757
Height 16.00 mm
Single use: yes
On the market
PERSONA® 42-5112-007-10
Zimmer, Inc.
42-5112-007-10 / 42-5112-007-1000889024640788
Height 10.00 mm
Single use: yes
On the market
PERSONA® 42-5114-005-11
Zimmer, Inc.
42-5114-005-11 / 42-5114-005-1100889024641198
Height 11.00 mm
Single use: yes
On the market
PERSONA® 42-5114-006-18
Zimmer, Inc.
42-5114-006-18 / 42-5114-006-1800889024641327
Height 18.00 mm
Single use: yes
On the market
PERSONA® 42-5210-003-10
Zimmer, Inc.
42-5210-003-10 / 42-5210-003-1000889024641884
Height 10.00 mm
Single use: yes
On the market
PERSONA® 42-5212-001-16
Zimmer, Inc.
42-5212-001-16 / 42-5212-001-1600889024642287
Height 16.00 mm
Single use: yes
On the market
PERSONA® 42-5212-002-14
Zimmer, Inc.
42-5212-002-14 / 42-5212-002-1400889024642355
Height 14.00 mm
Single use: yes
On the market
PERSONA® 42-5212-007-20
Zimmer, Inc.
42-5212-007-20 / 42-5212-007-2000889024642782
Height 20.00 mm
Single use: yes
On the market
PERSONA® 42-5214-001-18
Zimmer, Inc.
42-5214-001-18 / 42-5214-001-1800889024642850
Height 18.00 mm
Single use: yes
On the market
PERSONA® 42-5214-002-20
Zimmer, Inc.
42-5214-002-20 / 42-5214-002-2000889024642942
Height 20.00 mm
Single use: yes
On the market
PERSONA® 42-5214-003-12
Zimmer, Inc.
42-5214-003-12 / 42-5214-003-1200889024642973
Height 12.00 mm
Single use: yes
On the market
PERSONA® 42-5214-003-20
Zimmer, Inc.
42-5214-003-20 / 42-5214-003-2000889024643024
Height 20.00 mm
Single use: yes
On the market
PERSONA® 42-5214-004-16
Zimmer, Inc.
42-5214-004-16 / 42-5214-004-1600889024643086
Height 16.00 mm
Single use: yes
On the market
PERSONA® 42-5214-005-14
Zimmer, Inc.
42-5214-005-14 / 42-5214-005-1400889024643154
Height 14.00 mm
Single use: yes
On the market
PERSONA® 42-5214-008-20
Zimmer, Inc.
42-5214-008-20 / 42-5214-008-2000889024643420
Height 20.00 mm
Single use: yes
On the market
PERSONA® 42-5399-075-02
Zimmer, Inc.
42-5399-075-02 / 42-5399-075-0200889024247543
Single use: no
On the market
PERSONA® 42-5400-000-35
Zimmer, Inc.
42-5400-000-35 / 42-5400-000-3500889024643710
Single use: yes
On the market
PERSONA® Natural Tibia® 42-5321-071-01
Zimmer, Inc.
42-5321-071-01 / 42-5321-071-0100889024595828
Single use: no
On the market
Persona® The Personalized Knee® 42-5174-008-10
Zimmer, Inc.
42-5174-008-10 / 42-5174-008-1000889024238831
Single use: no
On the market
Persona® The Personalized Knee® 42-5272-007-10
Zimmer, Inc.
42-5272-007-10 / 42-5272-007-1000889024245266
Single use: no
On the market
Persona® The Personalized Knee® 42-5279-003-00
Zimmer, Inc.
42-5279-003-00 / 42-5279-003-0000889024245747
Single use: no
On the market
Persona® The Personalized Knee® 42-5279-003-04
Zimmer, Inc.
42-5279-003-04 / 42-5279-003-0400889024245785
Single use: no
On the market
PERSONA™ 42-5110-006-14
Zimmer, Inc.
42-5110-006-14 / 42-5110-006-1400889024233294
Height 14 mm
Single use: yes
On the market
PERSONA™ 42-5112-002-13
Zimmer, Inc.
42-5112-002-13 / 42-5112-002-1300889024233508
Height 13 mm
Single use: yes
On the market
PERSONA™ 42-5114-004-12
Zimmer, Inc.
42-5114-004-12 / 42-5114-004-1200889024234215
Height 12 mm
Single use: yes
On the market
PERSONA™ 42-5114-007-13
Zimmer, Inc.
42-5114-007-13 / 42-5114-007-1300889024234468
Height 13 mm
Single use: yes
On the market
PERSONA™ 42-5210-002-11
Zimmer, Inc.
42-5210-002-11 / 42-5210-002-1100889024239494
Height 11 mm
Single use: yes
On the market
PERSONA™ 42-5210-004-18
Zimmer, Inc.
42-5210-004-18 / 42-5210-004-1800889024239685
Height 18 mm
Single use: yes
On the market
PERSONA™ 42-5212-007-13
Zimmer, Inc.
42-5212-007-13 / 42-5212-007-1300889024240414
Height 13 mm
Single use: yes
On the market
PERSONA™ 42-5214-001-10
Zimmer, Inc.
42-5214-001-10 / 42-5214-001-1000889024240469
Height 10 mm
Single use: yes
On the market
PERSONA™ 42-5214-003-16
Zimmer, Inc.
42-5214-003-16 / 42-5214-003-1600889024240674
Height 16 mm
Single use: yes
On the market
PERSONA™ 42-5214-006-13
Zimmer, Inc.
42-5214-006-13 / 42-5214-006-1300889024240896
Height 13 mm
Single use: yes
On the market
PERSONA™ 42-5214-007-10
Zimmer, Inc.
42-5214-007-10 / 42-5214-007-1000889024240940
Height 10 mm
Single use: yes
On the market
PERSONA™ Natural Tibia™ 42-5320-067-02
Zimmer, Inc.
42-5320-067-0200889024246683
Single use: yes
On the market
Zimmer Persona Knee System SSI004189
Zimmer, Inc.
SSI004189 / SSI00418900889024506824
Single use: no
On the market
Zimmer Persona Knee System SSI004269
Zimmer, Inc.
SSI004269 / SSI00426900889024508538
Single use: no
On the market
Zimmer Persona Knee System SSI004332
Zimmer, Inc.
SSI004332 / SSI00433200889024506909
Single use: no
On the market

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