RecallRadar

FDA Device recall Z-0660-2013

PT113950 PT HYBRID Glenoid Post Regenerex porous titanium construct Sterile R Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented

On 2013-01-16 the FDA classified a Class II recall of PT113950 PT HYBRID Glenoid Post Regenerex porous titanium construct Sterile R Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented by Biomet, citing 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 con….

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-0660-2013
ClassificationClass II
Statusterminated
Initiated2006-12-12
Published2013-01-16
Last updated2026-09-13 11:53 UTC
CompanyBiomet
DistributionUS

Product

PT113950 PT HYBRID Glenoid Post Regenerex porous titanium construct Sterile R Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented

Reason

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

Identifiers

code_info
Part 113950 Lot 093540, 093550,093570,093580,093590,093600,093610,093620,093720, 093730,093740,093760,093770,093780,28…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 history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0660-2013%22

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