RecallRadar

FDA Device recall Z-2527-2026

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

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

AgencyFDA Device
Recall numberZ-2527-2026
ClassificationClass II
Statusongoing
Initiated2026-05-20
Published2026-07-01
Last updated2026-09-13 11:58 UTC
CompanyZimmer
DistributionUS

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

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.