FDA Enforcement
Class II
Terminated
Zimmer M/DN¿ Intramedullary Fixation Humeral Guide Wire - Bullet Tip, 2.4 mm Diameter, 70 cm Length Item Number: 00-2255-026-00 Product Usage: A single use surgical instrument used during orthopaedic surgery for implantation of a prosthesis.
Recall: Z-0532-2019
·
Reported December 12, 2018
Enforcement
- Recall Number
- Z-0532-2019
- Event ID
- 81394
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Zimmer Biomet, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- December 12, 2018
- Initiation Date
- October 22, 2018
- Classification Date
- November 30, 2018
- Termination Date
- December 30, 2020
- Address
- 1800 W Center St, N/A, Warsaw, IN, 46580-2304, United States
Description
Zimmer M/DN¿ Intramedullary Fixation Humeral Guide Wire - Bullet Tip, 2.4 mm Diameter, 70 cm Length Item Number: 00-2255-026-00 Product Usage: A single use surgical instrument used during orthopaedic surgery for implantation of a prosthesis.
Reason
Various Trauma Guide Wires- creases in the sealing area on the end opposite of the product's chevron opening compromising product sterility
Code Info
All lots expiring prior to September 30, 2023
Distribution
Worldwide - US Nationwide Distribution Foreign: CANADA AUSTRALIA BRAZIL CHILE HONG KONG JAPAN MALAYSIA NETHERLANDS NICARAGUA SINGAPORE TAIWAN
Quantity
780