Home / Recalls / Biomet Microfixation, LLC / Z-0518-2015

Z-0518-2015 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- 50mm Lft Standard Ti Mandi Reconstruction of the temporomandibular joint

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 24-6551TI, Lot #s: 544160A, 525190A, 525190B, 525180B, 544170A, 544180B, 544160B, 525180A, 544180A.

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-0509-2015 Class II — Total Temporomandibular Joint Replacement System- 45mm Lft Narrow Ti Mand (October 17, 2014)
  • Z-0511-2015 Class II — Total Temporomandibular Joint Replacement System- 45mm Rt Narrow Ti Mand Recons (October 17, 2014)