Official recall notice
FDA DeviceClass IINotable
FDA Recall: Off-Axis Comprehensive Shoulder System Small, Augment, Off-Axis, Reamer Guide, Model/Catalog Number:
- Recall date
- 2026-07-01
- Brand
- Zimmer, Inc.
- Category
- Medical Device
- FDA class
- Class II
Why it was recalled
Hazard
Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.
Product description
Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.
Affected products
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