medical MODERATE Updated 2026-07-01

Zimmer, Inc. recalls Off-Axis Comprehensive Shoulder System Small, Augment, Off-A

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Recalled Product

Off-Axis Comprehensive Shoulder System Small, Augment, Off-Axis, Reamer Guide, Model/Catalog Number: 110040240

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Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot Code: Model No. 110040240 ; UDI-DI (01)00889024681965(17)350601(10)099457 ; Lot Number 099457 Model No. 110040240 ; UDI-DI (01)00889024681965(17)350712(10)099458 ; Lot Number 099458

✅ What Should You Do?

  1. 1Contact your healthcare provider immediately to discuss this recall.
  2. 2Stop using the device if it is safe to do so, and contact your provider.
  3. 3Follow the manufacturer's remedy instructions provided in the recall notice.
  4. 4Report device problems to FDA MedWatch or call 1-800-FDA-1088.
View official government recall