Reported Jan 16, 2013 · Terminated
PT113950 PT HYBRID Glenoid Post Regenerex porous titanium construct Sterile R Prosthesis, Shoulder, Semi-Constrained,…
Biomet, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Biomet, Inc. · 56 E Bell Dr · Warsaw, IN · 46582-6989
Is this the product you have?
- PT113950 PT HYBRID Glenoid Post Regenerex porous titanium construct Sterile R Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
- Lot codes and dates
Part 113950 Lot 093540093550093570093580093590093600093610093620093720093730093740093760093770093780282590282600282620282630282680282700282710489160489180489200489210489770489780489790714480714550714570714700714730722210722250722280984770984780984790984800984810984820984830984840and 984850
- Amount recalled
- 1050
Where it was sold
- Nationwide
Why it was 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
This product could cause temporary or reversible health problems — stop using it.
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