Zimmer Periarticular Locking Plate (ZPLP) Distal Lateral Femoral Plate 6 holes 159 mm Length-Indi...

FDA Device Recall #Z-2254-2023 — Class II — June 27, 2023

Recall Summary

Recall Number Z-2254-2023
Classification Class II — Moderate risk
Date Initiated June 27, 2023
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Zimmer, Inc.
Location Warsaw, IN
Product Type Devices
Quantity 75 units

Product Description

Zimmer Periarticular Locking Plate (ZPLP) Distal Lateral Femoral Plate 6 holes 159 mm Length-Indicated for temporary internal fixation and stabilization of osteotomies and fractures, including comminuted fractures, supracondylar fractures, intra-articular and extra-articular condylar fractures, fractures in osteopenic bone, nonunions, and malunions. Item Number: 00235710106

Reason for Recall

Thread form issue of the locking holes in that the locking screws would not properly mate with the plate. The improperly mated screw may not be readily recognizable by the user since the screw may not correctly lock.

Distribution Pattern

AR AZ MA ME MO NJ NM NY OR WA Foreign: Brazil China Dominican Republic Korea Netherlamds Taiwan

Lot / Code Information

Lot Number/UDI: 64254511 /(01)0089024055940(10)64254511; 64296571/(01)0089024055940(10)64296571; 65379087/(01)0089024055940(10)65379087; 65379093/(01)0089024055940(10)65379093; 65379096/(01)0089024055940(10)65379096

Other Recalls from Zimmer, Inc.

Recall # Classification Product Date
Z-1946-2026 Class II Brand Name: Disposable Mixing Bowls with Spatul... Mar 30, 2026
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

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.