Z-3176-2018 Class II Terminated
FDA device recall Z-3176-2018 was initiated by Zimmer Biomet, Inc. on Jul 20, 2018 and is designated Class II. Reason for recall: The Gentle Thread PLGA Round Head, 7x20mm and the Gentle Thread PLGA Full Thread 10x30 have been commingled. The recall status is terminated (terminated Jun 4, 2020). Affected quantity: 52.
Recall Details
- Product Type
- Devices
- Report Date
- Sep 26, 2018
- Initiation Date
- Jul 20, 2018
- Termination Date
- Jun 4, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 52
Product Description
Gentle Thread PLGA Round Head Interference Screw, 7x20mm, Item Number 905612
Reason for Recall
The Gentle Thread PLGA Round Head, 7x20mm and the Gentle Thread PLGA Full Thread 10x30 have been commingled.
Distribution Pattern
The products were distributed to the following US states: IN, TN. The products were distributed to the following foreign countries: Australia, Chile, Netherlands.
Code Information
Lot Number 611330, UDI (1)00880304008526(17)221010(10)611330
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-3176-2018
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026