medical Class II Updated 2018-10-03

Zimmer Biomet, Inc. recalls Zimmer Natural Nail Tibial Nail - Yellow 8.3mm, Model Number

Recalled Product

Zimmer Natural Nail Tibial Nail - Yellow 8.3mm, Model Number 47249534008 Product Usage - The Zimmer Natural Nail System is intended for temporary fracture fixation and stabilization of the bone. Indications for the Tibial nails include the following in the tibia: Compound and simple shaft fractures Proximal, metaphyseal and distal shaft fractures Segmental fractures Comminuted fractures Fractures involving osteopenic and osteoporotic bone Pathological fractures Fractures with bone loss Pseudoarthrosis, non-union, mal-union and delayed union Periprosthetic fractures Surgically created defects such as osteotomies. Product Usage - The Zimmer Natural Nail System is intended for temporary fracture fixation and stabilization of the bone. Indications for the Tibial nails include the following in the tibia: Compound and simple shaft fractures Proximal, metaphyseal and distal shaft fractures Segmental fractures Comminuted fractures Fractures involving osteopenic and osteoporotic bone Pathological fractures Fractures with bone loss Pseudoarthrosis, non-union, mal-union and delayed union Periprosthetic fractures Surgically created defects such as osteotomies.


Hazard / Issue

The item is labeled as an 8.3mm, but it is actually a 12 mm.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: UDI: (01)00889024097551(17)190228(10)61169228R, Lot 61169228R
View official government recall

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