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8.5mm Reamer Head for Flexible Intramedullary Nailing System; An orthopedic manual surgical instr...

FDA Device Recall #Z-2359-2015 — Class II — July 1, 2015

Recall Summary

Recall Number Z-2359-2015
Classification Class II — Moderate risk
Date Initiated July 1, 2015
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Synthes (USA) Products LLC
Location West Chester, PA
Product Type Devices
Quantity 4329

Product Description

8.5mm Reamer Head for Flexible Intramedullary Nailing System; An orthopedic manual surgical instrument is a nonpowered hand-held device intended for medical purposes to manipulate tissue or for use with other devices in orthopedic surgery. This generic type of device includes the cerclage applier, awl, bender, drill brace, broach, burr, corkscrew, countersink, pin crimper, wire cutter, prosthesis driver, extractor, file, fork, needle holder, impactor, bending or contouring instrument, compression instrument, passer, socket positioner, probe, femoral neck punch, socket pusher, reamer, rongeur, scissors, screwdriver, bone skid, staple driver, bone screw starter, surgical stripper, tamp, bone tap, trephine, wire twister, and wrench.

Reason for Recall

The possibility exists for intraoperative reamer head breakages which could also allow for un-retrieved fragments of non-implant grade material: additional lot numbers identified. No new adverse events reported.

Distribution Pattern

Worldwide Distribution.

Lot / Code Information

Part Number 352.085, Sold lot numbers: 4399543 4411503 4420609 4425217 4500163 4500164 4500686 4516589 4606034 4606035 4619636 4631667 4646360 4658303 4660046 4676339 4691146 4691147 4705949 4720351 4720352 4757916 4769298 4769248 4799766 4790646 4798484 4856180 4882851 4899798 4919634 4937255 4937251 4956701 4956699 4977566 4994239 5018161 5018284 5034158 5034157 5050564 5052365 5065433 5087496 5102055 5102054 5124415 5124416 5140714 5140716 5161068 5185228 5203705 5226958 5226959 5248981 5249272 5249274 5249278 5294388 5299855 5299857 5299856 5299858 5362321 5454350 5454351 5471078 5493666 5508984 5535700 5554801 5575607 5582834 5610290 5635000 5652084 5665722 5697107 5718304 5735831 5756081 5769433 5784706 5813830 5837326 5870257 20141 20290 20291 21025 20713 21372 21677 21829 22717 20292 22981 21201 22592 23390 21927 23439 23944 24091 24334 24510 24917 24934 25076 25171 25178 4800264 4803085

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Z-1239-2024 Class II TFNA Femoral Nail 9mm, right, 130¿, L 235mm-In... Jan 24, 2024
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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.

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