PT113950 PT HYBRID Glenoid Post Regenerex porous recall
PT113950 PT HYBRID Glenoid Post Regenerex porous titanium construct Sterile R Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Why was PT113950 PT HYBRID Glenoid Post Regenerex porous recalled?
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
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- Product
- PT113950 PT HYBRID Glenoid Post Regenerex porous titanium construct Sterile R Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
- Recalling firm
- Biomet, Inc.
- Quantity
- 1050
- Distribution
- Worldwide Distribution -- US (nationwide) including the countries of , Canada, Japan, Argentina, Australia ,Netherlands, Europe and Chile.
- Recall date
- January 16, 2013
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)