Zimmer, Inc.: Off-Axis Comprehensive Shoulder System, Large, Augment, Off-Axis, Reamer Guide Model/Catalog Number: 110040242

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: 429 units Lot/code info: Lot Code: Model No. 110040242 ; UDI-DI (01)00889024681989(17)350601(10)099471 ; Lot Number 099471 Model No. 110040242 ; UDI-DI (01)00889024681989(17)350614(10)099473 ; Lot Number 099473 Model No. 110040242 ; UDI-DI (01)00889024681989(17)350804(10)099474 ; Lot Number 099474 Model No. 110040242 ; UDI-DI (01)00889024681989(17)350806(10)099475 ; Lot Number 099475

UPC codes

00889024681989

Source

Official record: FDA (Device enforcement) ↗

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