Zimmer Biomet, Inc.: Medical Device Recall in 2018 - (Recall #: Z-3246-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: July 30, 2018

Date Posted: October 3, 2018

Recall Number: Z-3246-2018

Event ID: 80879

Reason for Recall:

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

Status: Terminated

Product Quantity: 1 unit

Code Information:

UDI: (01)00889024097551(17)190228(10)61169228R, Lot 61169228R

Distribution Pattern:

The product was not distributed in the United States. The product was distributed in the Netherlands.

Voluntary or Mandated:

Voluntary: Firm initiated