Z-2897-2018 Class II Ongoing
FDA device recall Z-2897-2018 was initiated by Richard Wolf GmbH on Jul 24, 2017 and is designated Class II. 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. The recall status is ongoing. Affected quantity: 12 units.
Recall Details
- Product Type
- Devices
- Report Date
- Aug 29, 2018
- Initiation Date
- Jul 24, 2017
- 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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2897-2018
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026