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Zimmer, Inc. devices, product family

by Zimmer, Inc. 36 variants Basic UDI-DI 889024K4HT

Shared by every variant

Manufacturer
Zimmer, Inc.(36)
Basic UDI-DI
889024K4HT
Risk class
Class II
Legislation
—
EMDN category
—
Market status
36 on the market
Official record
EUDAMED public site — Open the EUDAMED public site, choose Devices, and search for the Basic UDI-DI 889024K4HT.

Recalls

20 recalls · FDA

  • Z-1224-2018 Class II · terminated · 12 Dec 2017
    A complaint was received for Item 42-5320-067-02, lot 63236047. It was report that there was no set screw or taper plug included in the box. Complaint investigation confirmed that the entire lot of 63236047 was missing the set screw and taper plug.
  • Z-1806-2018 Class II · terminated · 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.
  • Z-1808-2018 Class II · terminated · 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.
  • Z-1807-2018 Class II · terminated · 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.
  • Z-1805-2018 Class II · terminated · 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.
  • Z-1340-2016 Class II · terminated · 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.
  • Z-1341-2016 Class II · terminated · 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.
  • Z-1157-2016 Class II · terminated · 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.
  • Z-1360-2015 Class II · terminated · 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.
  • Z-0853-2015 Class II · terminated · 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
  • Z-1042-2015 Class II · terminated · 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
  • Z-0198-2015 Class II · terminated · 9 Oct 2014
    Cleaning process validation failure.
  • Z-0123-2015 Class II · terminated · 7 Oct 2014
    Affected product did not undergo heat treatment hardening step leading to the potential for deformation of the tip.
  • Z-2579-2014 Class II · terminated · 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.
  • Z-2580-2014 Class II · terminated · 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.
  • Z-2576-2014 Class II · terminated · 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.
  • Z-2575-2014 Class II · terminated · 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.
  • Z-2577-2014 Class II · terminated · 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.
  • Z-2578-2014 Class II · terminated · 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.
  • Z-2299-2014 Class II · terminated · 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.

Recalls matched to the 36 devices listed on this page; other pages of the family can carry others.

Variants

36 devices · page 1 of 1

Variants of Zimmer, Inc. devices, Basic UDI-DI 889024K4HT
UDI-DISize and differences
Persona® 42-5398-058-11 42-5398-058-11 / 42-5398-058-1100889024470347 —On the market
Persona® 42-5398-058-12 42-5398-058-12 / 42-5398-058-1200889024470354 —On the market
Persona® 42-5398-061-11 42-5398-061-11 / 42-5398-061-1100889024470361 —On the market
Persona® 42-5398-061-12 42-5398-061-12 / 42-5398-061-1200889024470378 —On the market
Persona® 42-5398-064-11 42-5398-064-11 / 42-5398-064-1100889024470385 —On the market
Persona® 42-5398-064-12 42-5398-064-12 / 42-5398-064-1200889024470392 —On the market
Persona® 42-5398-067-11 42-5398-067-11 / 42-5398-067-1100889024470408 —On the market
Persona® 42-5398-067-12 42-5398-067-12 / 42-5398-067-1200889024470415 —On the market
Persona® 42-5398-071-11 42-5398-071-11 / 42-5398-071-1100889024470422 —On the market
Persona® 42-5398-071-12 42-5398-071-12 / 42-5398-071-1200889024470439 —On the market
Persona® 42-5398-075-11 42-5398-075-11 / 42-5398-075-1100889024470446 —On the market
Persona® 42-5398-075-12 42-5398-075-12 / 42-5398-075-1200889024470453 —On the market
Persona® 42-5398-079-11 42-5398-079-11 / 42-5398-079-1100889024470460 —On the market
Persona® 42-5398-079-12 42-5398-079-12 / 42-5398-079-1200889024470477 —On the market
Persona® 42-5398-083-11 42-5398-083-11 / 42-5398-083-1100889024470484 —On the market
Persona® 42-5398-083-12 42-5398-083-12 / 42-5398-083-1200889024470491 —On the market
Persona® 42-5398-088-11 42-5398-088-11 / 42-5398-088-1100889024470507 —On the market
Persona® 42-5398-088-12 42-5398-088-12 / 42-5398-088-1200889024470514 —On the market
Persona® 42-5399-064-01 42-5399-064-01 / 42-5399-064-0100889024630543 —On the market
Persona® 42-5399-064-02 42-5399-064-02 / 42-5399-064-0200889024630550 —On the market
Persona® 42-5399-067-01 42-5399-067-01 / 42-5399-067-0100889024630567 —On the market
Persona® 42-5399-067-02 42-5399-067-02 / 42-5399-067-0200889024630574 —On the market
Persona® 42-5399-071-01 42-5399-071-01 / 42-5399-071-0100889024630581 —On the market
Persona® 42-5399-071-02 42-5399-071-02 / 42-5399-071-0200889024630598 —On the market
Persona® 42-5399-075-02 42-5399-075-02 / 42-5399-075-0200889024630611 —On the market
Persona® 42-5399-079-01 42-5399-079-01 / 42-5399-079-0100889024630628 —On the market
Persona® 42-5399-079-02 42-5399-079-02 / 42-5399-079-0200889024630635 —On the market
Persona® 42-5399-083-01 42-5399-083-01 / 42-5399-083-0100889024630642 —On the market
Persona® 42-5399-083-02 42-5399-083-02 / 42-5399-083-0200889024630659 —On the market
Persona® 42-5399-088-01 42-5399-088-01 / 42-5399-088-0100889024630666 —On the market
Persona® 42-5399-088-02 42-5399-088-02 / 42-5399-088-0200889024630673 —On the market
Persona® Knee System 42-5399-061-01 42-5399-061-01 / 42-5399-061-0100889024630529 —On the market
Persona® Knee System 42-5399-061-02 42-5399-061-02 / 42-5399-061-0200889024630536 —On the market
Persona® Knee System 42-5399-075-01 42-5399-075-01 / 42-5399-075-0100889024630604 —On the market
PERSONA™ 42-5399-058-01 42-5399-058-01 / 42-5399-058-0100889024247437 —On the market
PERSONA™ 42-5399-058-02 42-5399-058-02 / 42-5399-058-0200889024247444 —On the market