outer box: Ref 906768, CurvTek Eye Needle 22 MM X-large Stainless Steel, Single Use Gamma Steril...

FDA Device Recall #Z-0523-2014 — Class II — November 26, 2013

Recall Summary

Recall Number Z-0523-2014
Classification Class II — Moderate risk
Date Initiated November 26, 2013
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Biomet, Inc.
Location Warsaw, IN
Product Type Devices
Quantity 21

Product Description

outer box: Ref 906768, CurvTek Eye Needle 22 MM X-large Stainless Steel, Single Use Gamma Sterilized, Rx inner incorrect label: CurvTek 7 MM Medium, Single Pack Quantity -3, REF 906760 To pass the CurvTek needle, place the jaws of the instrument utilized to grasp the needle on the sides of the needle and orient and needle parallel to the long axis of the instrument. Position the needle to follow the path of the tunnel created by the cartridges. This aligns the needle with the radius of the transosseous tunnel. Advance the needle while rotating the instrument away from the entry point. Gently feed the needle through the length of the tunnel.

Reason for Recall

Inner label of PN: 906768 Lot: 055450 CurvTek Eye Needle 22mm X-Large states incorrectly PN: 906760 7mm Medium.

Distribution Pattern

Nationwide Distribution including MI, IA, IL, IN, and TN.

Lot / Code Information

Lot 055450

Other Recalls from Biomet, Inc.

Recall # Classification Product Date
Z-0212-2026 Class II BIOMET ZipTight, Acute AC Joint Implant, Single... Sep 23, 2025
Z-2619-2025 Class II Juggerknot Mini Soft Anchors, Model/Catalog Num... Sep 9, 2025
Z-0477-2025 Class II JuggerLoc/ToggleLoc 2.9mm Drill Guide, Model nu... Oct 21, 2024
Z-2179-2024 Class II RingLoc Bi-Polar Hip System Acetabular Cup, 41 ... May 17, 2024
Z-1607-2024 Class II Vanguard Knee System AS Tibial Bearing / DCM Ar... Mar 13, 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.