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BALL TIP GUIDE WIRE 3.2MMX98CM; 469060 Intended to be used as a guide pin for insertion of im...

FDA Device Recall #Z-2232-2018 — Class II — May 16, 2018

Recall Summary

Recall Number Z-2232-2018
Classification Class II — Moderate risk
Date Initiated May 16, 2018
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Zimmer Biomet, Inc.
Location Warsaw, IN
Product Type Devices
Quantity 4790

Product Description

BALL TIP GUIDE WIRE 3.2MMX98CM; 469060 Intended to be used as a guide pin for insertion of implants (cannulated screws and/or intramedullary nails). Bone nail guidewire. Intended for drilling bone.

Reason for Recall

The firm is recalling various trauma guide wires due to insufficient packaging design verification and exceeding the expected occurrence rate of complaints for sterile barrier failure. Guide wires packaged in the affected packaging configuration have the potential for sterile barrier breach, leading to possible risk for infection.

Distribution Pattern

Worldwide Distribution: US (Nationwide) and countries of: Argentina, South Korea, Chile, Colombia, Trinidad and Tobago, El Salvador, Costa Rica, Canada, Australia, Japan, and Netherlands.

Lot / Code Information

206660 230706 336160 361630 233262 448180 239047 700990 726170 828140 251680 828150 828100 932260 991350 991420 257058 152610 244850 244840 579040 579060 607290 662730 266560 746130 891170 832130 945420 275658 277507 083000 283676 473260 473270 769460 769470 809470 855610 466680 466700 466690 870170 983590 983770 983780 983600 342490 342560 342580 342590 342600 342610 342620 351370 351360 714680 422590 422610 422640 639830 741180 916630 934020 181790 462670 492510 492520 579490 929360 152000 362310 266540 687720 383870 384390 400980 824370 316600 316610 316630 316620 056630 056640 241130 241120 433960 838690 284980 284990 284960 720780 031840 220850 233970 291970 891450 891460 978430 159640 224200 515930 643890 907460 520050 141150 401760 495360 895470 223120 858380 822490 822500 822510 080760 108480 274700 773730 931830 683150 391810 391820 391830 370500 599560 120420 120430 175580 695660 399290 399300 692960 172710 172730 929090 963120 963130

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Frequently Asked Questions

Sterility recalls for medical devices vary in severity. If you have already had a procedure using a potentially non-sterile device, contact your healthcare provider immediately — you may need monitoring for signs of infection. Symptoms to watch for include fever, redness or swelling at the surgical site, unusual pain, or discharge. For devices that have not yet been used, they should be quarantined and returned to the manufacturer per the recall notice. Non-sterile implants can cause serious infections; early detection and treatment are critical.

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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