Zimmer, Inc.: Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509400 Software Version: N/A Product Description: Affixus 9 mm

Hazard

Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention.

Details from the source

Reason for recall: Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention. Distribution: US Nationwide distribution in the states of AL, AZ, CA, FL, IN, KY, MA, MO, MT, NC, NM, RI, TX, UT. Quantity: 23 Lot/code info: Lot Code: Model No 815509400 ; UDI-DI (01)00887868143564(17)340821(10)66717555 ; Lot Number 66717555 Model No 815509400 ; UDI-DI (01)00887868143564(17)340822(10)66884565 ; Lot Number 66884565 Model No 815509400 ; UDI-DI (01)00887868143564(17)350801(10)67379212 ; Lot Number 67379212

UPC codes

00887868143564

Source

Official record: FDA (Device enforcement) ↗

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