Z-1469-2018 Class II Terminated
FDA device recall Z-1469-2018 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
Zimmer Natural Nail System Tear Drop Guide Wire 3.0 mm Diameter, 100 cm Length; Item Number: 47-2490-097-00
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: 63609177 63631715 63638172 63638173 63638175 63638176 63645643 63645644 63655990 63655991 63655992 63655993 63655994 63662538 63662539 63662540 63662541 63668694 63668695 63668696 63668697 63675668 63675669 63675670 63675704 63675705 63681724 63681726 63681728 63690176 63690179 63690180 63705228 63705229 63709163 63709164 63709165 63709166 63715680 63715681 63715682 63715683 63721368 63721369 63721370 63721371 63731169 63748392 63753760 63753761 63753762 63753763 63758420 63758421 63758422 63758423 63771066 63771067 63780119 63780120 63780121 63780122 63781875 63781876 63781877 63781878 63787475 63787476 63787477 63796531 63796532 63796533 63796534 63796535 63803579 63803581 63803583 63803591 63803592 63812281 63812283 63812284 63812285 63817702 63817704 63817705 63844026 63812282 63817701 63826234 63826235 63836285 63844028
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1469-2018
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026