Agency classClass IIOur severity:High FDA (Devices)·Z-0660-2013·Announced 2013-01-16

Biomet Recalls PT Hybrid Glenoid Post Due to Oversized Thread

Biomet is recalling PT Hybrid Glenoid Posts because an oversized male thread may prevent the post from seating fully, potentially creating a gap in the implant.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a structural defect in a medical device that could lead to implant failure or complications, but the source text does not report any injuries, illnesses, or deaths, fitting the 'High' severity criteria for risk-of-harm products without reported injury.

Plain-English summary

Biomet, Inc. is recalling the PT113950 PT Hybrid Glenoid Post, a sterile, semi-constrained shoulder prosthesis component. The recall follows an investigation that identified the male thread of the post may be oversized. This condition can vary in degree and may lead to the post not being fully seated into the Hybrid Base if the implant construct is implanted, resulting in a gap of 1-3 mm.

The affected product is distributed worldwide, including the United States, Canada, Japan, Argentina, Australia, the Netherlands, Europe, and Chile. The recall covers 1,050 units across multiple specific lot numbers.

Consumers and healthcare providers should contact Biomet for further instructions regarding the return or replacement of these specific lots.

The recalled product

Product: PT113950 PT HYBRID Glenoid Post Regenerex porous titanium construct Sterile R Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Manufacturer: Biomet, Inc.
Category: Medical Device — Orthopedic Implant
Hazard: structural-defect
implant-failure
Affected units: 1,050

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

Part 113950 Lot 093540
093550
093570
093580
093590
093600
093610
093620
093720
093730
093740
093760
093770
093780
282590
282600
282620
282630
282680
282700

Distribution

Distributed nationwide across the United States.

Same manufacturer · Biomet, Inc.

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