FDA Device recall Z-2527-2026
Off-Axis Comprehensive Shoulder System Small, Augment, Off-Axis, Reamer Guide, Model/Catalog Number: 110040240
- FDA Device
- Class II
- ongoing
- Published 2026-07-01
On 2026-07-01 the FDA classified a Class II recall of Off-Axis Comprehensive Shoulder System Small, Augment, Off-Axis, Reamer Guide, Model/Catalog Number: 110040240 by Zimmer, citing five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2527-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-05-20 |
| Published | 2026-07-01 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Zimmer |
| Distribution | US |
Product
Off-Axis Comprehensive Shoulder System Small, Augment, Off-Axis, Reamer Guide, Model/Catalog Number: 110040240
Reason
Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.
Identifiers
| code_info | Lot Code: Model No. 110040240 ; UDI-DI (01)00889024681965(17)350601(10)099457 ; Lot Number 099457 Model No. 110040240 ;…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2527-2026%22
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