Device product
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.
Z-2897-2018
Product summary
- Event
- Event 80583
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 12 units
- Official record key
device-enforcement:Z-2897-2018
Official wording
Reason: Punch may have a burr in one section of the joint and when the punch is open, there is an increase potential for injury.
Code information: Product Number 89140.0105, Lot Number 4500197481
Distribution pattern: Worldwide distribution to Germany, Hong Kong, Ireland, Romania, and Turkey.
Derived failure modes
-
Unknown
Punch may have a burr in one section of the joint and when the punch is open, there is an increase potential for injury.