Z-1306-2018 Class II Terminated
FDA device recall Z-1306-2018 was initiated by Zimmer Biomet, Inc. on Oct 25, 2017 and is designated Class II. Reason for recall: The drill guides were manufactured with the incorrect color anodization. The recall status is terminated (terminated May 1, 2020). Affected quantity: 22.
Recall Details
- Product Type
- Devices
- Report Date
- Apr 11, 2018
- Initiation Date
- Oct 25, 2017
- Termination Date
- May 1, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 22
Product Description
A.L.P.S. MIS Calcaneus Locking Plate LG RT F.A.S.T. Guide inserts, Item Number: 816209003,UDI: 00887868044670989403
Reason for Recall
The drill guides were manufactured with the incorrect color anodization.
Distribution Pattern
Distributed in the following US States: AZ, MO, MT, NJ, NY, OH, TX, and WA. Distributed in Chile and Netherlands.
Code Information
Package Lot: 989430; Lot Etched on Product: P0284
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1306-2018
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026