Home / Recalls / Biomet Microfixation, LLC / Z-0509-2015

Z-0509-2015 Class II Terminated

Recalled by Biomet Microfixation, LLC — Jacksonville, FL

Recall Details

Product Type
Devices
Report Date
December 17, 2014
Initiation Date
October 17, 2014
Termination Date
January 4, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
42

Product Description

Total Temporomandibular Joint Replacement System- 45mm Lft Narrow Ti Mand

Reason for Recall

Laser etching on the parts is wider and deeper than the conditions previously validated.

Distribution Pattern

Worldwide Distribution - USA including PA, MN, CA and Internationally to Australia, Netherlands, France, and United Kingdom.

Code Information

Model 01-6546TI, Lot #s: 531880B, 535890B, 531870A, 531870B, 531880A, 535890D, 535890A, 535890C.

Other recalls by Biomet Microfixation, LLC

  • Z-2073-2017 Class II — Biomet Microfixation TraumaOne System Surgical Tray - Model # 46-1600 (April 11, 2017)
  • Z-2751-2016 Class II — Hard Tissue Replacement (HTR) Implant, Rx only, for use in single procedure only (June 13, 2016)
  • Z-0137-2016 Class II — Thinflap System Case The cases hold surgical instrumentation in place during ha (August 6, 2015)
  • Z-0136-2016 Class II — Neuro Combo Set Case The cases hold surgical instrumentation in place during ha (August 6, 2015)
  • Z-0519-2015 Class II — Total Temporomandibular Joint Replacement System- 55mm Lft Standard Ti Mand Rec (October 17, 2014)
  • Z-0513-2015 Class II — Total Temporomandibular Joint Replacement System- 50mm Lft Narrow Ti Mand Recon (October 17, 2014)
  • Z-0510-2015 Class II — Total Temporomandibular Joint Replacement System- 45mm Lft Stand Off Ti Mand Re (October 17, 2014)
  • Z-0512-2015 Class II — Total Temporomandibular Joint Replacement System- 45mm Rt Stand Off TI Mand Rec (October 17, 2014)
  • Z-0518-2015 Class II — Total Temporomandibular Joint Replacement System- 50mm Lft Standard Ti Mandi Re (October 17, 2014)
  • Z-0511-2015 Class II — Total Temporomandibular Joint Replacement System- 45mm Rt Narrow Ti Mand Recons (October 17, 2014)