Recall Z-0660-2013— Biomet, Inc.

Name: FDA recall Z-0660-2013
Creator: U.S. Food and Drug Administration
Published: 2006-12-12

Class II · Terminated

Class II FDA medical device recall by Biomet, Inc., initiated 2006-12-12, terminated 2013-11-08. It names one FDA 510(k) clearance: K060694. 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.

Recalling firm: Biomet, Inc.
Classification: Class II
Status: Terminated
Initiated: 2006-12-12
Terminated: 2013-11-08
Firm location: Warsaw, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K060694 — MODULAR HYBRID GLENOIDBiomet Manufacturing Corp·cleared 2006-12-11

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.