FDA DeviceClass IINotable

FDA Recall: Off-Axis Comprehensive Shoulder System, Large, Augment, Off-Axis, Reamer Guide Model/Catalog Number

Date: 2026-07-01
Brand: Zimmer, Inc.
Category: Medical Device
FDA Class: Class II

Description

Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.

Hazard

Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.

Remedy

429 units

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