Artholine Punch B 4, 6MM H 1, 6MM, used for the removal of soft tissue, cartilage tissue or othe...
FDA Device Recall #Z-2897-2018 — Class II — July 24, 2017
Recall Summary
| Recall Number | Z-2897-2018 |
| Classification | Class II — Moderate risk |
| Date Initiated | July 24, 2017 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Richard Wolf GmbH |
| Location | Knittlingen |
| Product Type | Devices |
| 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.
Lot / Code Information
Product Number 89140.0105, Lot Number 4500197481
Other Recalls from Richard Wolf GmbH
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1753-2025 | Class II | PiezoWave 2 Control Unit, Product Number 100506... | Apr 9, 2025 |
| Z-1423-2023 | Class II | FLEX. BIOPSY FORCEPS 5FR WL 550MM, Product Numb... | Mar 24, 2023 |
| Z-1422-2023 | Class II | FLEX. GRASP. FORCEPS 5FR WL 550MM, Product Numb... | Mar 24, 2023 |
| Z-1425-2023 | Class II | FLEX. GRASP. FORCEPS 6.6FR WL 550MM, Product Nu... | Mar 24, 2023 |
| Z-1424-2023 | Class II | FLEX. GRASP. FORCEPS 5FR WL 550MM, Product Numb... | Mar 24, 2023 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.