Zimmer, Inc.: Off-Axis Comprehensive Shoulder System, Medium, Augment, Off-Axis, Reamer Guide Model/Catalog Number: 110040241

Hazard

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

Details from the source

Reason for recall: Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage. Distribution: US Nationwide distribution. Quantity: 435 units Lot/code info: Lot Code: Model No. 110040241 ; UDI-DI (01)00889024681941(17)350602(10)099463 ; Lot Number 099463 Model No. 110040241 ; UDI-DI (01)00889024681941(17)350531(10)099464 ; Lot Number 099464 Model No. 110040241 ; UDI-DI (01)00889024681941(17)350812(10)099465 ; Lot Number 099465 Model No. 110040241 ; UDI-DI (01)00889024681941(17)350707(10)099467 ; Lot Number 099467

UPC codes

00889024681941

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.