Zimmer¿ Air Dermatome II Handpiece, item number 00-8851-001-00. The Zimmer Air Dermatome II h...
FDA Device Recall #Z-2334-2016 — Class II — July 4, 2016
Recall Summary
| Recall Number | Z-2334-2016 |
| Classification | Class II — Moderate risk |
| Date Initiated | July 4, 2016 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Zimmer Surgical Inc |
| Location | Dover, OH |
| Product Type | Devices |
| Quantity | 630 units |
Product Description
Zimmer¿ Air Dermatome II Handpiece, item number 00-8851-001-00. The Zimmer Air Dermatome II handpiece and width plates are packaged inside of a padded-foam corrugate box. An operating manual is packed with the handpiece between the top foam pad and box lid. A product label is applied to the lid of the box. The width plates, when sold individually, are placed in a labeled poly zipper bag, which is then placed into a corrugated shipper carton or padded envelope. The Zimmer Air Dermatome II is a skin grafting instrument that is intended to provide variable graft thickness and width capabilities.
Reason for Recall
The surface coating applied to the device is blistering, peeling and discoloring after usage over time
Distribution Pattern
US Nationwide Distribution including states of: AL, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, and WI.
Lot / Code Information
Lot # 61977101, Serial # 500001 500019 Lot # 61980678, Serial # 500021 500040 Lot # 61989398, Serial # 500081 500090 Lot # 62008619, Serial # 500091 500110 Lot # 62083340, Serial # 500151 500170 Lot # 62096333, Serial # 500171 500190 Lot # 62122378, Serial # 500191 500210 Lot # 62191658, Serial # 500211 500230 Lot # 62191665, Serial # 500231 500250 Lot # 62220857, Serial # 500251 500270 Lot # 62220882, Serial # 500291 500310 Lot # 62244236, Serial # 500331 500350 Lot # 62266024, Serial # 500351 500371 Lot # 62267510, Serial # 500372 500391 Lot # 62267596, Serial # 500452 500471 Lot # 62289834, Serial # 500412 500431 Lot # 62309628, Serial # 500472 500491 Lot # 62309698, Serial # 500512 500531 Lot # 62369392, Serial # 500532 500551 Lot # 62374685, Serial # 500552 500571 Lot # 62374721, Serial # 500592 500611 Lot # 62393971, Serial # 500632 500651 Lot # 62394012, Serial # 500652 500671 Lot # 62454338, Serial # 500692 500711 Lot # 62476761, Serial # 500712 500731 Lot # 62494048, Serial # 500732 500751 Lot # 62494086, Serial # 500752 500771 Lot # 62525837, Serial # 500772 500791 Lot # 62554526, Serial # 500792 500811 Lot # 62578715, Serial # 500812 500831 Lot # 62578759, Serial # 500832 500851 Lot # 62635778, Serial # 500852 500871
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.