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Recall Observatory FDA recall evidence

Device 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.

Z-3246-2018

July 30, 2018

Class II

Product summary

Firm
Zimmer Biomet, Inc.
Event
Event 80879
Status
Terminated
Classification
Class II
Quantity
1 unit
Official record key
device-enforcement:Z-3246-2018

Official wording

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

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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