3M Specialty Blade Assembly, REF 9660,70-2011-8462-2, 7100213114, used with used with 3M Surgical...
FDA Device Recall #Z-1169-2024 — Class II — January 12, 2024
Recall Summary
| Recall Number | Z-1169-2024 |
| Classification | Class II — Moderate risk |
| Date Initiated | January 12, 2024 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | 3M Company - Health Care Business |
| Location | Saint Paul, MN |
| Product Type | Devices |
| Quantity | 52,833,750 blades |
Product Description
3M Specialty Blade Assembly, REF 9660,70-2011-8462-2, 7100213114, used with used with 3M Surgical Clipper Catalog Number 9661L
Reason for Recall
3M has added the following cautionary statement regarding the use of the product: "Caution - To reduce the risk of burns, which if not avoided may result in minor injury: " Do not use on injured skin. " Do not leave clipper running unused in air without applying to skin for more than 1 minute as blade temperature may exceed 41¿C (105.8¿F). " Do not leave the clipper blade applied to the same location on the patient s skin for longer than 1 second as potential injury may occur; continuous motion of the clipper during use is required. Note: If clipper is left running unused in air for 10 minutes without applying to skin, the Model 9690 blade maximum temperature may reach 60¿C (140¿F) and the Model 9660 blade maximum temperature may reach 77¿C (170.6¿F)."
Distribution Pattern
Worldwide distribution.
Lot / Code Information
UDI/DI 50707387789003 (shipper), 30707387789009 (tray), all lot codes
Other Recalls from 3M Company - Health Care Business
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0743-2025 | Class II | Clarity Precision Grip Attachments, for use in ... | Nov 22, 2024 |
| Z-0038-2025 | Class II | 3M Tegaderm CHG, Chlorhexidine Gluconate I.V. S... | Aug 14, 2024 |
| Z-1633-2024 | Class II | 3M Durapore Surgical Tape, Catalog Number 1538-118 | Mar 20, 2024 |
| Z-1475-2024 | Class II | 3M Tube Securement Device, Small, 1.7 IN/PO x 2... | Feb 20, 2024 |
| Z-1170-2024 | Class II | 3M Specialty Blade Assembly, REF 9660,70-2011-8... | Jan 12, 2024 |
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.