Z-3246-2018 Class II Terminated
FDA device recall Z-3246-2018 was initiated by Zimmer Biomet, Inc. on Jul 30, 2018 and is designated Class II. Reason for recall: The item is labeled as an 8.3mm, but it is actually a 12 mm. The recall status is terminated (terminated Oct 24, 2019). Affected quantity: 1 unit.
Recall Details
- Product Type
- Devices
- Report Date
- Oct 3, 2018
- Initiation Date
- Jul 30, 2018
- Termination Date
- Oct 24, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1 unit
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.
Reason for Recall
The item is labeled as an 8.3mm, but it is actually a 12 mm.
Distribution Pattern
The product was not distributed in the United States. The product was distributed in the Netherlands.
Code Information
UDI: (01)00889024097551(17)190228(10)61169228R, Lot 61169228R
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-3246-2018
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026