Speed Stitch Needle Cassette

FDA Device Recall #Z-2999-2020 — Class II — August 17, 2020

Recall Summary

Recall Number Z-2999-2020
Classification Class II — Moderate risk
Date Initiated August 17, 2020
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm ArthroCare Corporation
Location Austin, TX
Product Type Devices
Quantity 6,366 needles

Product Description

Speed Stitch Needle Cassette

Reason for Recall

Due to a supplier error where a portion of the raw material was inadvertently mixed. As a result, some needles may be made of commercially pure titanium as opposed to 304 stainless steel which does not meet the specification and could potentially break during use.

Distribution Pattern

Domestic Distribution: AK, AL, AR, AZ, CA, CO, CT,DB,FL,GA, HI, IA, ID, IL, IN, KS, KY, MA,MD,ME,MI,MN,MO,MS,MT, NC,ND, NE, NJ, NSW, NV,NY, OH,OK, OR, PA,SC, TN,TX, UT, VA, WA, WI, WV. International Distribution: AE, AU, CH, DE, FI, FR, GB, HK, IE, PA, PR, PT, RU, SG, and ZA

Lot / Code Information

Model: OM-8850 Lot Numbers: 2018434, 2018934, 2019558, 2019559, 2019929, 2019930, 2020931, 2022111, 2022641, 2030008, 2032212, 2033815, 2037604, 2036941, 2038701, 2039699, 2040500, 2042295, 2044957, 2047483, 2048575, 2051239 & 2032526

Other Recalls from ArthroCare Corporation

Recall # Classification Product Date
Z-3000-2020 Class II Smith&Nephew SmartStitch PerfectPasser Connecto... Feb 21, 2019
Z-1321-2016 Class II TOPAZ MicroDebrider 0.8 mm REF AC4040-01; TOPAZ... Mar 3, 2016
Z-0623-2016 Class II Cavity 8 Gauge Spine Wand indicated for resecti... Oct 26, 2015
Z-2105-2015 Class II EVac 70 XTRA with Integrated Cable and PROcise ... Jun 2, 2015

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.