NexGen® Complete Knee Solution 00-5917-020-14

• • Terminated Z-0324-2020 FDA Class II ·initiated 10 Oct 2019

  Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).

• 7 recalls, same reason

  • Terminated Z-1040-2018 FDA Class II ·initiated 29 Nov 2017
  • Terminated Z-1043-2018 FDA Class II ·initiated 29 Nov 2017
  • Terminated Z-1036-2018 FDA Class II ·initiated 29 Nov 2017
  • Terminated Z-1044-2018 FDA Class II ·initiated 29 Nov 2017
  • Terminated Z-1035-2018 FDA Class II ·initiated 29 Nov 2017
  • Terminated Z-1038-2018 FDA Class II ·initiated 29 Nov 2017
  • Terminated Z-1045-2018 FDA Class II ·initiated 29 Nov 2017

  The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag.

• • Terminated Z-0663-2018 FDA Class II ·initiated 24 Jul 2017

  There is a possibility that the protective foam insert used during the packaging of the affected products is undersized, which may cause a breach in the inner cavity during transportation.

• • Terminated Z-0841-2016 FDA Class II ·initiated 11 Jan 2016

  LDPE bag containing the implant adheres to the highly polished implant surface.

• • Terminated Z-0080-2014 FDA Class II ·initiated 30 Aug 2013

  The low density polyethylene (LDPE) bag used to package implants adheres to the highly polished surface of the devices.

• 4 recalls, same reason

  • Terminated Z-1521-2009 FDA Unclassified (pre-2012) ·initiated 17 Apr 2009
  • Terminated Z-1520-2009 FDA Unclassified (pre-2012) ·initiated 17 Apr 2009
  • Terminated Z-1522-2009 FDA Unclassified (pre-2012) ·initiated 17 Apr 2009
  • Terminated Z-1523-2009 FDA Unclassified (pre-2012) ·initiated 17 Apr 2009

  The implant surface may not have been polished adequately, which could result in increased wear and polyethylene debris generation.

Trade Name

NexGen® Complete Knee Solution

Generic Name

Tibial insert

Model / Ref / Catalog

00-5917-020-14

Primary DI / UDI-DI

00889024665132

PMA Number

P060037 ↗

FDA Product Code

NJL

GMDN Term

Tibial insert

Device Class

Class III

GUDID distribution status

In Commercial Distribution

MRI Safety

MR Conditional

Category: Tibial insert

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  Class IIa

  CE/MDR

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  Class I

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  Class I

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  Class IIa

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