Z-0537-2019 Class II Terminated
FDA device recall Z-0537-2019 was initiated by Zimmer Biomet, Inc. on Oct 22, 2018 and is designated Class II. Reason for recall: Various Trauma Guide Wires- creases in the sealing area on the end opposite of the product's chevron opening compromising product sterility The recall status is terminated (terminated Dec 30, 2020). Affected quantity: 48320.
Recall Details
- Product Type
- Devices
- Report Date
- Dec 12, 2018
- Initiation Date
- Oct 22, 2018
- Termination Date
- Dec 30, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 48320
Product Description
Zimmer Smooth Guide Wire - Bullet Tip, 3.0 mm Diameter, 100 cm Length Item Number: 47-2255-008-01 Product Usage: A single use surgical instrument used during orthopaedic surgery for implantation of a prosthesis.
Reason for Recall
Various Trauma Guide Wires- creases in the sealing area on the end opposite of the product's chevron opening compromising product sterility
Distribution Pattern
Worldwide - US Nationwide Distribution Foreign: CANADA AUSTRALIA BRAZIL CHILE HONG KONG JAPAN MALAYSIA NETHERLANDS NICARAGUA SINGAPORE TAIWAN
Code Information
All lots expiring prior to September 30, 2023
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0537-2019
- openFDA file date
- Oct 21, 2026
- Loaded by RegDataLab
- Oct 23, 2026