FDA DeviceClass IINotable

FDA Recall: Off-Axis Comprehensive Shoulder System Small, 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

474 units

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