Home / Recalls / Biomet Microfixation, LLC / Z-2566-2014

Z-2566-2014 Class II Terminated

Recalled by Biomet Microfixation, LLC — Jacksonville, FL

Recall Details

Product Type
Devices
Report Date
September 10, 2014
Initiation Date
September 20, 2013
Termination Date
October 3, 2014
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1

Product Description

Biomet Microfixation Temporomandibular Joint (TMJ) Patient Matched Left Fossa Part# CP751506 The Total Temporomandibular Joint (TMJ) replacement system is implanted in the jaw to functionally reconstruct a diseased and/or damaged temporomandibular joint. The Total TMJ replacement system is a two-component system comprised of mandibular condyle and a glenoid fossa components. Both components are available in multiple stock sizes as right and left specific designs and are attached to the bones by screws.

Reason for Recall

Product mix occurred prior to final package and labeling process.

Distribution Pattern

Worldwide Distribution to Denmark only.

Code Information

Part #CP751506 Lot #478490

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  • Z-2751-2016 Class II — Hard Tissue Replacement (HTR) Implant, Rx only, for use in single procedure only (June 13, 2016)
  • Z-0136-2016 Class II — Neuro Combo Set Case The cases hold surgical instrumentation in place during ha (August 6, 2015)
  • Z-0137-2016 Class II — Thinflap System 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-0518-2015 Class II — Total Temporomandibular Joint Replacement System- 50mm Lft Standard Ti Mandi Re (October 17, 2014)