The Zimmer Air Dermatome, REF 00- 8801- 001- 00 , Rx, non-sterile grafting instruments inten...

FDA Device Recall #Z-1483-2013 — Class II — May 7, 2013

Recall Summary

Recall Number Z-1483-2013
Classification Class II — Moderate risk
Date Initiated May 7, 2013
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Zimmer Surgical Inc
Location Dover, OH
Product Type Devices
Quantity 84 units

Product Description

The Zimmer Air Dermatome, REF 00- 8801- 001- 00 , Rx, non-sterile grafting instruments intended to provide variable graft thickness and width capabilities

Reason for Recall

This removal is in response to complaints alleging that the Zimmer Air Dermatomes and Zimmer Air Dermatome II products would either not operate or operate intermittently. Zimmer's investigation determined that the planetary gear teeth were broken. This may cause a delay or postponement of the surgery or result in a suboptimal graft retrieval with potential of requiring an additional donor site.

Distribution Pattern

Worldwide distribution: USA Nationwide including Puerto Rico; UAE, TAIWAN, SWEDEN, THAILAND, KOREA, SINGAPORE, HONG KONG CHINA, CHILE, CANADA, AUSTRALIA, JAPAN, ENGLAND, GERMANY, and EGYPT.

Lot / Code Information

Serial Number 100211, 100338, 100515, 100560, 100647, 100755, 101104, 101345, 101562, 101769, 101890, 101983, 102560, 103407, 103509, 103816, 104529, 104863, 105049, 105072, 105604, 106394, 106474, 106624, 107861, 108103, 108203, 108210, 108339, 108911, 109445, 109543, 110034, 110837, 111046, 111047, 111048, 111049, 111050, 111051, 111052, 111053, 111054, 111055, 111056, 111057, 111058, 111059, 111060, 111061, 111062, 111063, 111064, 111065, 111066, 111067, 111068, 111069, 111071, 111072, 111073, 111074, 111075, 111076, 111079, 111081, 111083, 111084, 111085, 111086, 111087, 111089, 111090, 111091, 111092, 111096, 111100, 111101, 111102, 111104, 111105, 111116, 111121, 111122

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.