Z-2897-2018 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- August 29, 2018
- Initiation Date
- July 24, 2017
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 12 units
Product Description
Artholine Punch B 4, 6MM H 1, 6MM, used for the removal of soft tissue, cartilage tissue or other non-osseous tissue via natural or surgically created passages. Product Usage: Device is a standard punch; standard punches are used for the removal of soft tissue, cartilage tissue or other non-osseous tissue via natural or surgically created passages.
Reason for Recall
Punch may have a burr in one section of the joint and when the punch is open, there is an increase potential for injury.
Distribution Pattern
Worldwide distribution to Germany, Hong Kong, Ireland, Romania, and Turkey.
Code Information
Product Number 89140.0105, Lot Number 4500197481