PT113950 PT HYBRID Glenoid Post Regenerex porous titanium construct Sterile R Prosthesis, Sh...
FDA Recall #Z-0660-2013 — Class II — December 12, 2006
Product Description
PT113950 PT HYBRID Glenoid Post Regenerex porous titanium construct Sterile R Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Reason for Recall
Biomet is recalling Part Number PT-113950 PT Hybrid Glenoid Post, following an investigation which identified that the male thread of the post may be oversized. This oversized condition can vary in degree and may lead to the following three events: 1) If the PT Hybrid Glenoid Post is not fully seated into the Hybrid Base and the implant construct is implanted, then a gap of 1-3 mm will be prese
Recalling Firm
Biomet, Inc. — Warsaw, IN
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
1050
Distribution
Worldwide Distribution -- US (nationwide) including the countries of , Canada, Japan, Argentina, Australia ,Netherlands, Europe and Chile.
Code Information
Part 113950 Lot 093540, 093550,093570,093580,093590,093600,093610,093620,093720, 093730,093740,093760,093770,093780,282590,282600,282620,282630, 282680,282700,282710,489160,489180,489200,489210,489770,489780, 489790,714480,714550,714570,714700,714730,722210,722250,722280, 984770,984780,984790,984800,984810,984820,984830,984840, and 984850
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated