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

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: 474 units Lot/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

UPC codes

00889024681965

Source

Official record: FDA (Device enforcement) ↗

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