LT DISC ULNA - HA/PC; RT DISC ULNA - HA/PC; LT DISC HMRL- HA/PC; RT DISC HMRL- HA/PC; DISC XS U...
FDA Device Recall #Z-0532-2020 — Class II — August 21, 2019
Recall Summary
| Recall Number | Z-0532-2020 |
| 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 | 217240 |
Product Description
LT DISC ULNA - HA/PC; RT DISC ULNA - HA/PC; LT DISC HMRL- HA/PC; RT DISC HMRL- HA/PC; DISC XS ULNA POR; DISC SEG ULNA POR; and Custom devices Item Nos. 114754 114755 114744 114745 114704 114705 114756 114757 114714 114715 114746 114747 114706 114707 114758 114759 114716 114717 114748 114749 114708 114709 114718 114719 CP561429 CP561430 CP561431 CP561432 CP561442 CP561449 CP561488 CP561489 CP561709 CP561710 CP561714 CP561715 PM555203 Product Usage: Total Elbow Replacement
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: 098150 098170 885530 551700 582640 860410 537600 998440 536200 349800 020980 452110 650490 632550 649570 776070 411420 021170 537440 850110 762800 217470 349790 452100 342680 367650 537660 688030 192120 394130 826480 829870 094600 668330 997920 776390 537690 129330 452180 094590 630340 529650 641720 418260 635230 094850 418270 561370 688000 143470 452090 631460 766880 044090 630470 188230 880350 119800 418230 952290 418240 041340 209730 537810 687990 143430 050740 452080 202130 378110 172700 630460 958490 887520 367640 762820 537750 452160 833840 500460 632400 342690 691260 418250 537820 688020 452150 452140 378140 630490 668320 438130 561380 751430 095380 612060 630280 776060 222580 418220 537640 687980 349780 963310 594050 648930 631250 649560 880340 119740 144470 493280 997930 537630 762810 452130 378130 630480 367660 146740 537800 688010 093600 349810 535250 535270 650510 631550 776080 429290 493290 109620 533440 533450 858000 762790 533430 829980 687970 758850 376960 533190 419200 533240 109600 533170 863110 533180 109610 533420 533270 762780 341130 803330 751660 405540 533150 533110 701360 254200 763550 883670 313970 209510 095440 742890 550340 143650 533260 597860 819130 094020 014060 533250 020810 473360 094010 478110 095430 533140 383870 701950 217960 802880 094000 762770 533120 533130 UDI: (01)00880304436343(17)201208(10)650490 (01)00880304436343(17)201208(10)632550 (01)00880304436343(17)210512(10)649570 (01)00880304436343(17)210606(10)776070 (01)00880304436343(17)210824(10)411420 (01)00880304436343(17)220206(10)021170 (01)00880304435964(17)210425(10)342680 (01)00880304435964(17)210812(10)367650 (01)00880304435933(17)210203(10)094600 (01)00880304435933(17)210822(10)668330 (01)00880304435940(17)210203(10)094590 (01)00880304435940(17)201228(10)630340 (01)00880304435940(17)210219(10)529650 (01)00880304435940(17)210219(10)641720 (01)00880304435940(17)210706(10)418260 (01)00880304435940(17)210723(10)635230 (01)00880304435940(17)210907(10)094850 (01)00880304435940(17)211110(10)418270 (01)00880304434295(17)201228(10)631460 (01)00880304434295(17)210122(10)766880 (01)00880304434295(17)210125(10)044090 (01)00880304434295(17)210407(10)630470 (01)00880304434295(17)210416(10)188230 (01)00880304434295(17)210617(10)880350 (01)00880304434295(17)210620(10)119800 (01)00880304434295(17)210820(10)418230 (01)00880304434295(17)210822(10)952290 (01)00880304434295(17)210822(10)418240 (01)00880304434295(17)211110(10)041340 (01)00880304434295(17)211129(10)209730 (01)00880304434837(17)210310(10)378110 (01)00880304434837(17)210407(10)172700 (01)00880304434837(17)210425(10)630460 (01)00880304434837(17)210607(10)958490 (01)00880304434837(17)210607(10)887520 (01)00880304434837(17)210809(10)367640 (01)00880304435957(17)210107(10)632400 (01)00880304435957(17)210607(10)342690 (01)00880304435957(17)210721(10)691260 (01)00880304435957(17)210721(10)418250 (01)00880304434455(17)210210(10)378140 (01)00880304434455(17)210330(10)630490 (01)00880304434455(17)210906(10)668320 (01)00880304434332(17)201204(10)630280 (01)00880304434332(17)210812(10)776060 (01)00880304434332(17)210906(10)222580 (01)00880304434332(17)210912(10)418220 (01)00880304435056(17)201204(10)648930 (01)00880304435056(17)201204(10)631250 (01)00880304435056(17)210520(10)649560 (01)00880304435056(17)210608(10)880340 (01)00880304435056(17)210621(10)119740 (01)00880304435056(17)210901(10)144470 (01)00880304435056(17)221029(10)493280 (01)00880304436008(17)210210(10)378130 (01)00880304436008(17)210315(10)630480 (01)00880304436008(17)210830(10)367660 (01)00880304436008(17)210906(10)146740 (01)00880304434448(17)201209(10)650510 (01)00880304434448(17)201228(10)631550 (01)00880304434448(17)210607(10)776080 (01)00880304434448(17)210707(10)429290 (01)00880304434448(17)230221(10)493290 (01)00880304435971(17)250911(10)819130 (01)00880304435971(17)260728(10)094020 (01)00880304434387(17)251211(10)473360 (01)00880304434387(17)261101(10)094010 (01)00880304437500(17)260714(10)802880 (01)00880304437500(17)260720(10)094000
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.