FDA DevicesClass II
Off-Axis Comprehensive Shoulder System Small, Augment, Off-Axis, Reamer Guide, M...
Published: July 1, 2026Recall ID: Z-2527-2026Category: devicesCountry: US
Reason for Recall / Hazard
Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.
Product Description & Identification
Off-Axis Comprehensive Shoulder System Small, Augment, Off-Axis, Reamer Guide, Model/Catalog Number: 110040240
Additional Source Details
| Field | Value |
|---|---|
| City | Warsaw |
| State | IN |
| Event id | 99045 |
| Address 1 | 1800 W Center St |
| Address 2 | N/A |
| 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 |
| Postal code | 46580-2304 |
| Report date | 20260701 |
| Product type | Devices |
| Product quantity | 474 units |
| Reason for recall | Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260520 |
| Initial firm notification | N/A |
| Center classification date | 20260623 |
Overview
- Recalling FirmZimmer, Inc.
- StatusOngoing
- Risk LevelClass II
- DistributionUS Nationwide distribution.