Zimmer Dermatome Blades- 10-pack boxes of blades. Intended for use with the dermatome handpiece w...
FDA Device Recall #Z-0069-2024 — Class II — September 5, 2023
Recall Summary
| Recall Number | Z-0069-2024 |
| Classification | Class II — Moderate risk |
| Date Initiated | September 5, 2023 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Zimmer Surgical Inc |
| Location | Dover, OH |
| Product Type | Devices |
| Quantity | 11,985 boxes (119,850 blades) |
Product Description
Zimmer Dermatome Blades- 10-pack boxes of blades. Intended for use with the dermatome handpiece which is a skin grafting instrument that is intended to provide variable graft thickness and width capabilities Part number: 00880000010
Reason for Recall
Skin grafts thin and non-uniform when using the affected blades. The issue would be identified at the time of use and may result in the need for additional harvests to adequately cover the area
Distribution Pattern
US Nationwide Foreign: AUSTRALIA BRAZIL CHINA HONG KONG INDIA JAPAN MALAYSIA MEXICO NETHERLANDS ON SEOUL SINGAPORE TAIWAN THAILAND
Lot / Code Information
FG (Blade) UDI: (01)00889024375895(17)280205(10)65599469 (01)00889024375895(17)280206(10)65620875 (01)00889024375895(17)280207(10)65621233 (01)00889024375895(17)280209(10)65630969 (01)00889024375895(17)280212(10)65647382 (01)00889024375895(17)280213(10)65648460 (01)00889024375895(17)280214(10)65709066 (01)00889024375895(17)280219(10)65925347 (01)00889024375895(17)280220(10)65925348 (01)00889024375895(17)280221(10)65935737 (01)00889024375895(17)280223(10)65935738 (01)00889024375895(17)280319(10)65952857 (01)00889024375895(17)280424(10)65952858 (01)00889024375895(17)280430(10)65972711 (01)00889024375895(17)280503(10)65972712 (01)00889024375895(17)280507(10)65988623 (01)00889024375895(17)280426(10)65952862 (01)00889024375895(17)280509(10)65988624 (01)00889024375895(17)280514(10)65989036 (01)00889024375895(17)280516(10)65989037 (01)00889024375895(17)280520(10)66000975 (01)00889024375895(17)280523(10)66000976 (01)00889024375895(17)280528(10)66002852 (01)00889024375895(17)280530(10)65952860 (01)00889024375895(17)280610(10)66002853 (01)00889024375895(17)280613(10)66014333 (01)00889024375895(17)280617(10)66014332 (01)00889024375895(17)280624(10)66038885 (01)00889024375895(17)280628(10)66172214 (01)00889024375895(17)280710(10)66049031 (01)00889024375895(17)280724(10)66078057 (01)00889024375895(17)280719(10)66049032 Sales Unit (Box) UDI (01)00889024380318(17)280205(10)65599469 (01)00889024380318(17)280206(10)65620875 (01)00889024380318(17)280207(10)65621233 (01)00889024380318(17)280209(10)65630969 (01)00889024380318(17)280212(10)65647382 (01)00889024380318(17)280213(10)65648460 (01)00889024380318(17)280214(10)65709066 (01)00889024380318(17)280219(10)65925347 (01)00889024380318(17)280220(10)65925348 (01)00889024380318(17)280221(10)65935737 (01)00889024380318(17)280223(10)65935738 (01)00889024380318(17)280319(10)65952857 (01)00889024380318(17)280424(10)65952858 (01)00889024380318(17)280430(10)65972711 (01)00889024380318(17)280503(10)65972712 (01)00889024380318(17)280507(10)65988623 (01)00889024380318(17)280426(10)65952862 (01)00889024380318(17)280509(10)65988624 (01)00889024380318(17)280514(10)65989036 (01)00889024380318(17)280516(10)65989037 (01)00889024380318(17)280520(10)66000975 (01)00889024380318(17)280523(10)66000976 (01)00889024380318(17)280528(10)66002852 (01)00889024380318(17)280530(10)65952860 (01)00889024380318(17)280610(10)66002853 (01)00889024380318(17)280613(10)66014333 (01)00889024380318(17)280617(10)66014332 (01)00889024380318(17)280624(10)66038885 (01)00889024380318(17)280628(10)66172214 (01)00889024380318(17)280710(10)66049031 (01)00889024380318(17)280724(10)66078057 (01)00889024380318(17)280719(10)66049032 Lot Numbers: 65599469 65620875 65621233 65630969 65647382 65648460 65709066 65925347 65925348 65935737 65935738 65952857 65952858 65972711 65972712 65988623 65952862 65988624 65989036 65989037 66000975 66000976 66002852 65952860 66002853 66014333 66014332 66038885 66172214 66049031 66078057 66049032
Other Recalls from Zimmer Surgical Inc
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1202-2026 | Class II | Brand Name: Zimmer Tourniquet Systems Product ... | Dec 24, 2025 |
| Z-1201-2026 | Class II | Brand Name: Zimmer Tourniquet Systems Product ... | Dec 24, 2025 |
| Z-0924-2026 | Class II | Zimmer Air Dermatome, Model/Catalog Number: 008... | Nov 24, 2025 |
| Z-0925-2026 | Class II | Zimmer Dermatome AN, Model/Catalog Number: 8871... | Nov 24, 2025 |
| Z-1078-2024 | Class II | 3:1 Dermacarrier, Model Number 00219501300, ski... | Jan 2, 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.