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

Class I - Dangerous

🏥 Medical Devices Recalled: August 21, 2019 Zimmer Biomet Other Medical Devices Nationwide

What Should You Do?

Check if you have this product:
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
Do not eat it: Even if it looks and smells fine, do not consume this product.
Throw it away or return it: You can return the product to the store for a full refund.
Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:: Zimmer Biomet, Inc.
Reason for Recall:: Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue.
Classification:: Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
Status:: terminated

Product Information

Full 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

Product Codes/Lot Numbers:

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

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0532-2020

Related Recalls

Spinal Rod Cutter, Item number 00392500200. The product is a nonsterile pin cutter - Product Usage: The intended use of this instrument is to be used for cutting orthopedic rods/pins during orthopedic surgeries.

Zimmer Biomet

Class I - Dangerous

Device has the potential for fracture during use.

Nov 20, 2020 Surgical Instruments Nationwide View Details →

Polaris 5.5 Spinal System and Polaris 5.5/Cypher Spinal System, Thoracolumbosacral pedicle screw system

Zimmer Biomet

Class I - Dangerous

Zimmer Biomet is conducting a medical device correction to update the Instructions for Use (IFU) and the Surgical Techniques for the Polaris Spinal System Translation Screw and Cypher MIS Screw System. Users should be aware that changes were made to the contraindications section indicating that the Translation Screws should not be used with a direct current stimulation, as a high probability of construct failure exists when using Translation Screws containing CoCr with direct current simulation system.

Nov 17, 2020 Other Medical Devices Nationwide View Details →

ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, Neutral, O.D. Cup with Spacers, 55 mm Item Number: 00-8065-552-32

Zimmer Biomet

Class I - Dangerous

Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions.

Sep 24, 2020 Other Medical Devices Nationwide View Details →