2.0MM BALL NOSE GUIDE WIRE, Item Nos. 281017006 - Product Usage: These instruments and delivery s...
FDA Device Recall #Z-0531-2020 — Class II — August 21, 2019
Recall Summary
| Recall Number | Z-0531-2020 |
| Classification | Class II — Moderate risk |
| Date Initiated | August 21, 2019 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Zimmer Biomet, Inc. |
| Location | Warsaw, IN |
| Product Type | Devices |
| Quantity | 2708 |
Product Description
2.0MM BALL NOSE GUIDE WIRE, Item Nos. 281017006 - Product Usage: These instruments and delivery systems are used to facilitate implantation of orthopedic medical devices.
Reason for Recall
Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue.
Distribution Pattern
US Nationwide distribution and countries of Argentina, Australia, Brazil, Canada, Chile, Colombia, Costa Rica, Ecuador, El Salvador, Italy, Netherlands, India, Japan, Korea, Malaysia, Mexico, New Zealand, Panama, Singapore, Taiwan, Thailand, Trinidad and Tobago, and Venezuela.
Lot / Code Information
LOTS: 206322 062980 062690 062720 062740 062760 062950 062960 062970 730390 730400 730380 158530 158510 158520 460220 859610 860250 661640 977840 977850 114600 167450 204150 204160 204180 204190 204200 204210 678430 491410 678420 233730 233770 392590 233710 233720 694090 039330 039340 039350 039360 039370 039380 039450 039420 039390 039400 039410 039430 039440 039460 039470 113340 994740 036320 036330 665740 994730 036290 204970 204990 205000 205010 205020 472130 164579 164582 164586 164587 206318 206319 206320 206321 260820 260821 270166 270167 AF6AE7000 AT9AG7 B5KAT7 B5LAA7 B78AE7 B78AF7 BD3AA7 BT9AD7 BX2AB7 CN8AG7 CN8AH7 CW3AT7 CW3AV7 CW3AV7R CW3AW7 CW3AW7R CW3AX7 E3SAB7 E3SAC7 EG9AF7 EG9AG7 EG9AH7 EG9AJ7 NXW351U NXW351V UDI: (01)00887868029448(17)220501(10)206322 (01)00887868029448(17)240819(10)062980 (01)00887868029448(17)240819(10)062690 (01)00887868029448(17)240819(10)062720 (01)00887868029448(17)240819(10)062740 (01)00887868029448(17)240819(10)062760 (01)00887868029448(17)240819(10)062950 (01)00887868029448(17)240819(10)062960 (01)00887868029448(17)240819(10)062970 (01)00887868029448(17)241013(10)730390 (01)00887868029448(17)241013(10)730400 (01)00887868029448(17)241013(10)730380 (01)00887868029448(17)241101(10)158530 (01)00887868029448(17)241103(10)158510 (01)00887868029448(17)241103(10)158520 (01)00887868029448(17)241201(10)460220 (01)00887868029448(17)250115(10)859610 (01)00887868029448(17)250116(10)860250 (01)00887868029448(17)250410(10)661640 (01)00887868029448(17)250429(10)977840 (01)00887868029448(17)250429(10)977850 (01)00887868029448(17)250601(10)114600 (01)00887868029448(17)250601(10)167450 (01)00887868029448(17)250921(10)204150 (01)00887868029448(17)250921(10)204160 (01)00887868029448(17)250921(10)204180 (01)00887868029448(17)250921(10)204190 (01)00887868029448(17)250922(10)204200 (01)00887868029448(17)250922(10)204210 (01)00887868029448(17)260614(10)678430 (01)00887868029448(17)260623(10)491410 (01)00887868029448(17)260108(10)678420 (01)00887868029448(17)260111(10)233730 (01)00887868029448(17)260111(10)233770 (01)00887868029448(17)260616(10)392590 (01)00887868029448(17)260111(10)233710 (01)00887868029448(17)260111(10)233720 (01)00887868029448(17)260403(10)694090 (01)00887868029448(17)260502(10)039330 (01)00887868029448(17)260502(10)039340 (01)00887868029448(17)260502(10)039350 (01)00887868029448(17)260502(10)039360 (01)00887868029448(17)260505(10)039370 (01)00887868029448(17)260505(10)039380 (01)00887868029448(17)260524(10)039450 (01)00887868029448(17)260525(10)039420 (01)00887868029448(17)260525(10)039390 (01)00887868029448(17)260525(10)039400 (01)00887868029448(17)260525(10)039410 (01)00887868029448(17)260525(10)039430 (01)00887868029448(17)260525(10)039440 (01)00887868029448(17)260525(10)039460 (01)00887868029448(17)260525(10)039470 (01)00887868029448(17)260610(10)113340 (01)00887868029448(17)260610(10)994740 (01)00887868029448(17)260623(10)036320 (01)00887868029448(17)260623(10)036330 (01)00887868029448(17)260623(10)665740 (01)00887868029448(17)260623(10)994730 (01)00887868029448(17)260701(10)036290 (01)00887868029448(17)260718(10)204970 (01)00887868029448(17)260718(10)204990 (01)00887868029448(17)260718(10)205000 (01)00887868029448(17)260718(10)205010 (01)00887868029448(17)260718(10)205020
Other Recalls from Zimmer Biomet, Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0696-2021 | Class II | Spinal Rod Cutter, Item number 00392500200. The... | Nov 20, 2020 |
| Z-0570-2021 | Class II | Polaris 5.5 Spinal System and Polaris 5.5/Cyphe... | Nov 17, 2020 |
| Z-0372-2021 | Class II | ZCA All Poly Acetabular Cup Longevity Crosslink... | Sep 24, 2020 |
| Z-0345-2021 | Class II | ZCA All Poly Acetabular Cup Longevity Crosslink... | Sep 24, 2020 |
| Z-0347-2021 | Class II | ZCA All Poly Acetabular Cup Longevity Crosslink... | Sep 24, 2020 |
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.