Zimmer¿ Air Dermatome II Width Plate, 1 in., item number 00-8851-201-00 . Width plates is pack...

FDA Device Recall #Z-2336-2016 — Class II — July 4, 2016

Recall Summary

Recall Number Z-2336-2016
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 70 units

Product Description

Zimmer¿ Air Dermatome II Width Plate, 1 in., item number 00-8851-201-00 . Width plates is packaged inside of a padded-foam corrugate box. 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 # 61999883, Serial # N/A Lot # 62243337, Serial # N/A Lot # 62282028, Serial # N/A Lot # 62393990, Serial # N/A

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.