Oxford Partial Knee System 154616

• FDA PMA P010014 decided 21 Apr 2004 Active
• FDA GUDID UDI-DI 05019279388233 listed 29 Aug 2014 Listed

• 20 recalls, same reason

  • Terminated Z-1153-2017 FDA Class II ·initiated 5 Jan 2016 ·on shared PMA P010014
  • Terminated Z-1168-2017 FDA Class II ·initiated 5 Jan 2016 ·on shared PMA P010014
  • Terminated Z-1162-2017 FDA Class II ·initiated 5 Jan 2016
  • Terminated Z-1152-2017 FDA Class II ·initiated 5 Jan 2016 ·on shared PMA P010014
  • Terminated Z-1159-2017 FDA Class II ·initiated 5 Jan 2016
  • Terminated Z-1170-2017 FDA Class II ·initiated 5 Jan 2016 ·on shared PMA P010014
  • Terminated Z-1165-2017 FDA Class II ·initiated 5 Jan 2016
  • Terminated Z-1173-2017 FDA Class II ·initiated 5 Jan 2016
  • Terminated Z-1158-2017 FDA Class II ·initiated 5 Jan 2016
  • Terminated Z-1172-2017 FDA Class II ·initiated 5 Jan 2016
  • Terminated Z-1161-2017 FDA Class II ·initiated 5 Jan 2016
  • Terminated Z-1169-2017 FDA Class II ·initiated 5 Jan 2016 ·on shared PMA P010014
  • Terminated Z-1157-2017 FDA Class II ·initiated 5 Jan 2016
  • Terminated Z-1163-2017 FDA Class II ·initiated 5 Jan 2016
  • Terminated Z-1155-2017 FDA Class II ·initiated 5 Jan 2016 ·on shared PMA P010014
  • Terminated Z-1156-2017 FDA Class II ·initiated 5 Jan 2016
  • Terminated Z-1154-2017 FDA Class II ·initiated 5 Jan 2016 ·on shared PMA P010014
  • Terminated Z-1164-2017 FDA Class II ·initiated 5 Jan 2016
  • Terminated Z-1160-2017 FDA Class II ·initiated 5 Jan 2016
  • Terminated Z-1171-2017 FDA Class II ·initiated 5 Jan 2016

  Zimmer Biomet is conducting a medical device field action for various lot-specific Oxford Knee instruments due to potential alumina inclusions in the raw material batch used to produce the affected products. Inclusions contained within the finished product could lead to the cracking and separation of the instrument.

• • Terminated Z-2698-2011 FDA Unclassified (pre-2012) ·initiated 22 Apr 2011 ·on shared PMA P010014

  This recall was initiated due to a customer complaint which reported that while peeling off the Tyvek lid on the blister pack, very little effort was required to remove it and this could lead to contamination of the device.

• • Terminated Z-0962-2009 FDA Unclassified (pre-2012) ·initiated 19 Dec 2008

  Packages labeled as "right" actually contain a "left" component.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

1. 5 Jan 2016 Recall initiated FDA recalls Z-1161-2017
2. 5 Jan 2016 Recall initiated FDA recalls Z-1169-2017
3. 5 Jan 2016 Recall initiated FDA recalls Z-1157-2017
4. 5 Jan 2016 Recall initiated FDA recalls Z-1163-2017
5. 5 Jan 2016 Recall initiated FDA recalls Z-1155-2017
6. 5 Jan 2016 Recall initiated FDA recalls Z-1156-2017
7. 5 Jan 2016 Recall initiated FDA recalls Z-1154-2017
8. 5 Jan 2016 Recall initiated FDA recalls Z-1164-2017
9. 5 Jan 2016 Recall initiated FDA recalls Z-1160-2017
10. 5 Jan 2016 Recall initiated FDA recalls Z-1171-2017

14 earlier events are in the sections above.

Trade name

Oxford Partial Knee System

Generic name

Unicondylar knee prosthesis

Model / Ref / Catalog

154616

Primary DI / UDI-DI

05019279388233

PMA number

P010014 ↗

FDA product code

NRA

GMDN term

Unicondylar knee prosthesis

Device class

Class III

GUDID distribution status

In Commercial Distribution

MRI safety

MR Conditional

Category: Unicondylar knee prosthesis

• Vanguard™ Complete Knee System

  Class I

  CE/MDR

• Oxford® Partial Knee System

  Class III

  CE/MDR MDR 754277 Expiring Valid to Nov 2027

• Vanguard® Knee System

  Class I

  CE/MDR

• Vanguard® Complete Knee System

  Class I

  CE/MDR

See all devices from Biomet Uk Ltd →