Z-1471-2018 Class II Terminated
FDA device recall Z-1471-2018 was initiated by Zimmer Biomet, Inc. on Mar 26, 2018 and is designated Class II. Reason for recall: Potential failure of sterile packaging seal. The recall status is terminated (terminated Nov 18, 2020). Affected quantity: 19483 total products.
Recall Details
- Product Type
- Devices
- Report Date
- May 2, 2018
- Initiation Date
- Mar 26, 2018
- Termination Date
- Nov 18, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 19483 total products
Product Description
Pressure Sentinel Intramedullary Reaming System Guide Wire Bullet Tip 2.4 mm Diameter; Item Number: 00-2228-024-00
Reason for Recall
Potential failure of sterile packaging seal.
Distribution Pattern
US Nationwide and the following countries: Brazil, Singapore, Canada, Australia, Japan, Malaysia, Chile, Netherlands, Trinidad
Code Information
Lot Numbers: 63655999 63715685 63731170 63733045 63812299
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1471-2018
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026