Z-0540-2019 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- December 12, 2018
- Initiation Date
- October 22, 2018
- Termination Date
- December 30, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 12724
Product Description
Zimmer Natural Nail¿ System - Tear Drop Guide Wire, 3.0 mm Diameter, 70 cm Length Item Number: 47-2490-098-00 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