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Persona® 42-5212-006-13

by Zimmer, Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None ongoing

39 closed

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00889024642669 UDI-DI Date25 Feb 2022ListedStatusListed GUDID: in commercial distribution

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

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Persona®
Generic Name
Tibial insert
Model / Ref / Catalog
42-5212-006-13
Primary DI / UDI-DI
00889024642669
510(k) Number
FDA Product Code
JWH
GMDN Term
Tibial insert
Device Class
Class II
Regulation Number
888.3560
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Conditional
Size
Height — 13.00 Millimeter

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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