Metasul¿ Durom¿ Femoral component Sterile, Rx

FDA Device Recall #Z-0216-2013 — Class II — September 4, 2012

Recall Summary

Recall Number Z-0216-2013
Classification Class II — Moderate risk
Date Initiated September 4, 2012
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Zimmer, Inc.
Location Warsaw, IN
Product Type Devices
Quantity 209

Product Description

Metasul¿ Durom¿ Femoral component Sterile, Rx

Reason for Recall

Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Wintetthur, Switzerland, after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct, the info

Distribution Pattern

Nationwide Distribution.

Lot / Code Information

REF Numbers: 01.00211.140, 01.00211.144, 01.00211.152, 01.00211.154. 01.00211.156, 01.00211.158, and 01.00211.160. Lot: 2367454, 2367454, 2367454, 2367454, 2367455, 2367455, 2374382, 2374382, 2374382, 2374382, 2381632, 2381632, 2381634, 2381634, 2409055, 2414048, 2397713, 2397713, 2417888, 2380622, 2380622, 2388389, 2388389, 2388389, 2453506, 2422704, 2375235, 2375235, 2375235, 2394700, and 2508571

Other Recalls from Zimmer, Inc.

Recall # Classification Product Date
Z-0981-2026 Class II Brand Name: Affixus Antegrade Femoral Nailing S... Dec 2, 2025
Z-0979-2026 Class II Brand Name: Affixus Antegrade Femoral Nailing S... Dec 2, 2025
Z-0973-2026 Class II Brand Name: Affixus Antegrade Femoral Nailing S... Dec 2, 2025
Z-0977-2026 Class II Brand Name: Affixus Antegrade Femoral Nailing S... Dec 2, 2025
Z-0967-2026 Class II Brand Name: Affixus Antegrade Femoral Nailing S... Dec 2, 2025

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.