Brand Name: Persona¿ Anterior Referencing Sizer with Locking Boom The Persona Anterior Referenci...

FDA Device Recall #Z-1360-2015 — Class II — March 10, 2015

Recall Summary

Recall Number Z-1360-2015
Classification Class II — Moderate risk
Date Initiated March 10, 2015
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Zimmer, Inc.
Location Warsaw, IN
Product Type Devices
Quantity 688

Product Description

Brand Name: Persona¿ Anterior Referencing Sizer with Locking Boom The Persona Anterior Referencing Sizer is a sterilizable instrument intended for use in multiple total knee arthroplasty procedures. The Persona Surgical Technique (97-5026-001-00, Rev. 9) states that the sizer helps ensure that the desired external rotation is attained and provides a size for the femoral component.

Reason for Recall

Zimmer, Inc is voluntarily recalling 22 lots of Persona¿ Anterior Referencing Sizer with Locking Boom, part number 42-5099-088-10. Devices are being removed from distribution due to nonconforming to print specifications.

Distribution Pattern

Worldwide Distribution - US including Domestic: Puerto Rico, AZ, NY. OR, ME, NC, OH, TX, CO, IL, TN, PA, HI, CA, KS, WI, VA, MN, NJ, UT, MA, GA, MI, OK, MS, FL, AL, IN, and Internationally to Germany, India, Dominican Republic, Singapore, Korea, Japan, Austrailia, Canada.

Lot / Code Information

Part # 42-5099-088-10; Lots: 56573342; 56574505; 56574999; 56574229; 56574818; 56575000; 56574230; 56574819; 56575020; 56574301; 56574820; 56575021; 56574349; 56574861; 56575072; 56574374; 56574862; 56575105; 56574375; 56574863; 56574504; 56574998;

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.