GUIDE WIRE 2.2MM X 28IN, Aim/Art Guide wire, Item No. 809222028 - Product Usage: These instrument...
FDA Device Recall #Z-0529-2020 — Class II — August 21, 2019
Recall Summary
| Recall Number | Z-0529-2020 |
| 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 | 2468 |
Product Description
GUIDE WIRE 2.2MM X 28IN, Aim/Art Guide wire, Item No. 809222028 - 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: 323740 323770 323870 323970 324050 957830 957880 323840 323890 323910 323930 957800 987260 987480 987720 485140 486100 485470 485850 069570 069980 070100 977580 977670 977690 977700 977710 977720 977730 977750 661460 661440 661450 161370 166860 166870 166870R 108410 108350 108380 108390 108400 108430 108450 472150 392630 392650 392660 392680 233870 233900 471850 471860 471870 472140 472160 036430 036390 036370 036360 036400 036450 036380 036410 036420 036440 036460 121498 212067 270142 270144 270146 270149 270151 270153 A3WAA7 A3WAB7 A3WAC7 A4WAA7 A4WAC7 A4WAD7 AD4AB7000 ADJAB7000 AP8AC7 AP8AD7000 B3TAH7 BA8AA7 BY3AB7 C25AA7 C25AB7 C4YAA7 CA3AA7 CD8AA7 CW3AA7 CW3AB7 CW3AC7 D38AC7 D3CAC7 D3CAF7 D4EAD7 D4EADA D5VAJ7 D66AD7 DF9AA7 DH6AA7 DH6AA7R DN5AJ7 DV3AA7 DW7AA7 DW7AAA E2PAD7 E2PAE7 E2PAG7 E2YAD7 E36AC7 E45AD7 E4EAB7 E55AD7 E55AE7 E5CAB7 E5CAC7 E5VAJ7 EG9AA7 EP2AC7 EP9AC7 ES5AA7 EY2AC7 EY9AA7 FB1AA7 FB1AB7 FB8AB7 FB8AC7 W35AD7000 WS1AJ7000 XE7AW7000 Y1KAB7000 Y98AA7000 YJ7AA7000 Z78AA7000 ZJ2AA7000 ZJ5AA7000 ZJ5AAA UDI: (01)00887868034664(17)240619(10)323970 (01)00887868034664(17)240619(10)324050 (01)00887868034664(17)240708(10)957800 (01)00887868034664(17)240716(10)987260 (01)00887868034664(17)240717(10)987480 (01)00887868034664(17)240717(10)987720 (01)00887868034664(17)240828(10)485140 (01)00887868034664(17)240828(10)486100 (01)00887868034664(17)240829(10)485470 (01)00887868034664(17)240902(10)485850 (01)00887868034664(17)241015(10)069570 (01)00887868034664(17)241016(10)069980 (01)00887868034664(17)241017(10)070100 (01)00887868034664(17)250121(10)977580 (01)00887868034664(17)250122(10)977670 (01)00887868034664(17)250122(10)977690 (01)00887868034664(17)250122(10)977700 (01)00887868034664(17)250122(10)977710 (01)00887868034664(17)250122(10)977720 (01)00887868034664(17)250122(10)977730 (01)00887868034664(17)250122(10)977750 (01)00887868034664(17)250408(10)661460 (01)00887868034664(17)250408(10)661440 (01)00887868034664(17)250408(10)661450 (01)00887868034664(17)250601(10)161370 (01)00887868034664(17)250630(10)166860 (01)00887868034664(17)250601(10)166870 (01)00887868034664(17)250601(10)166870R (01)00887868034664(17)250902(10)108410 (01)00887868034664(17)250902(10)108350 (01)00887868034664(17)250902(10)108380 (01)00887868034664(17)250902(10)108390 (01)00887868034664(17)250902(10)108400 (01)00887868034664(17)250903(10)108430 (01)00887868034664(17)250903(10)108450 (01)00887868034664(17)260610(10)472150 (01)00887868034664(17)260630(10)392630 (01)00887868034664(17)260111(10)392650 (01)00887868034664(17)260111(10)392660 (01)00887868034664(17)260111(10)392680 (01)00887868034664(17)260111(10)233870 (01)00887868034664(17)260111(10)233900 (01)00887868034664(17)260616(10)471850 (01)00887868034664(17)260111(10)471860 (01)00887868034664(17)260610(10)471870 (01)00887868034664(17)260616(10)472140 (01)00887868034664(17)260623(10)472160 (01)00887868034664(17)260614(10)036430 (01)00887868034664(17)260616(10)036390 (01)00887868034664(17)260623(10)036370 (01)00887868034664(17)260624(10)036360 (01)00887868034664(17)260624(10)036400 (01)00887868034664(17)260624(10)036450 (01)00887868034664(17)260628(10)036380 (01)00887868034664(17)260628(10)036410 (01)00887868034664(17)260628(10)036420 (01)00887868034664(17)260628(10)036440 (01)00887868034664(17)260628(10)036460
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.