Persona® The Personalized Knee®, product family

Manufacturer

Zimmer, Inc.(20)

Basic UDI-DI

889024KWKX

Risk class

Class II

Legislation

—

EMDN category

—

Market status

20 on the market

Official record

EUDAMED public site — Open the EUDAMED public site, choose Devices, and search for the Basic UDI-DI 889024KWKX.

• 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-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-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-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-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-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-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-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-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-2296-2014 ·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.
• 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 20 devices listed on this page; other pages of the family can carry others.