Recall Z-0526-2020
Zimmer Biomet, Inc. · initiated August 21, 2019
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Various Custom Products, Item Nos. CP102940 CP102941 CP102942 CP102943 CP102944 CP102945 CP102946 CP102947 CP102948 CP112662 CP112663 CP112664 CP112674 CP112675 CP113771 CP113777 CP113778 CP113782 CP113783 CP114083 CP114090 CP114112 CP114118 CP114148 CP114213 CP114388 CP114436 CP114463 CP114472 CP114478 CP114495 CP114532 CP114561 CP114563 CP114605 CP114695 CP114756 CP114782 CP114783 CP114933 CP114987 CP115008 CP115048 CP115049 CP115050 CP115166 CP115209 CP115212 CP115312 CP115313 CP115314 CP115318 CP115319 CP115320 CP115322 CP115357 CP115358 CP115359 CP115360 CP115362 CP115363 CP115371 CP161304 CP161305 CP161306 CP161307 CP161522 CP161560 CP161735 CP161741 CP161751 CP161752 CP161753 CP161768 CP161793 CP161795 CP161831 CP161867 CP162006 CP162007 CP162008 CP162013 CP162017 CP162042 CP162043 CP162055 CP162084 CP162085 CP162086 CP162121 CP162149 CP162150 PM0000711 PM103016 PM103022 PM103060 PM155537 PM155577 PM155578 PM155580 PM155590 PM155591 PM155592 PM155594 PM155595 PM155602 PM155603 PM155604 PM155610 PM155612 PM155615 PM155616 PM155618 PM155623 PM155630 PM155635 PM155638 PM155640 PM155641 PM155643 PM155644 PM155646 PM155650 PM155653 PM155654 PM155656 PM155660 PM155662 PM155663 PM155677 PM155678 PM155685 PM155686 PM155687 PM155694 PM155698 PM155702 PM155710 PM155711 PM155712 PM155715 PM155717 PM155724 PM155725 PM155727 PM155728 PM155730 PM155734 PM155737 PM155738 PM155742 PM155746 PM155750 PM155751 PM155753 PM155756 PM155757 PM155761 PM155762 PM155767 PM155771 PM155774 PM155780 PM155781 PM155785 PM155789 PM155791 PM155792 PM155793 PM155795 PM155804 PM155806 PM155808 PM155809 PM155812 PM155813 PM155815 PM155818 PM155820 PM155823 PM155825 PM155828 PM155829 PM155840 PM155841 PM155842 PM155843 PM155847 PM155849 PM155850 PM155854 PM155857 PM155860 PM155863 PM155867 PM155868 PM155871 PM155872 PM155879 PM155882 PM155887 PM155888 PM155890 PM155892 PM155893 PM155894 PM155895 PM155897 PM155903 PM155905 PM155909 PM155913 PM155922 PM155926 PM155927 PM155928 PM155929 PM155933 PM155938 PM155939 PM155940 PM155942 PM155945 PM155947 PM155948 PM155950 PM155952 PM155963 PM155965 PM155972 PM155974 PM155979 PM155982 PM155983 PM155986 PM155988 PM155989 PM155991 PM155993 PM155997 PM155998 PM156000 PM156002 PM156007 PM156008 PM156012 PM156035 PM156038 PM156039 PM156041 PM156043 PM156044 PM156047 PM156048 PM156060 PM156061 PM156072 PM156079 PM156085 PM156092 PM156095 PM156101 PM156104 PM156110 PM156116 PM156132 PM156133 PM156143 PM156147 PM156154 PM156165 PM156166 PM156173 PM156184 PM156188 PM156192 PM156193 PM156197 PM156205 PM156207 PM156219 PM156235 PM156236 PM156244 PM156248 PM156254 PM156266 PM156275 PM156280 PM156281 PM156290 PM156292 PM156293 PM156320 PM156329 PM156340 PM156343 PM156345 PM156351 PM156352 PM156356 PM156357 PM156358 PM156362 PM156377 PM156379 PM156382 PM156384 PM156387 PM156388 PM156390 PM156391 PM156392 PM156393 PM156397 PM156402 PM156403 PM156405 PM156406 PM156409 PM156410 PM156431 PM156434 PM156435 PM156438 PM156444 PM156448 PM156453 PM156457 PM156458 PM156460 PM156477 PM156485 PM156489 PM156492 PM156497 PM156501 PM156510 PM156511 PM156520 PM156529 PM156532 PM156533 PM156539 PM156544 PM156546 PM156551 PM156560 PM156561 PM156563 PM156565 PM156567 PM156570 PM156572 PM156573 PM156578 PM156584 PM156589 PM156595 PM156596 PM156604 PM156605 PM156609 PM156610 PM156620 PM156632 PM156641 PM156643 PM156656 PM156663 PM156666 PM156668 PM156674 PM156675 PM156676 PM156680 PM156681 PM156682 PM156684 PM156688 PM156691 PM156692 PM156693 PM156698 PM156700 PM156704 PM156705 PM156713 PM156718 PM156803 PM156814 PM156821 PM156829 PM156830 PM156831 PM156834 PM15
Codes / lots: All lots manufactured from January 2008 - May 2019 458330 805800 098150 098170 551700 582720 484570 885530 027260 549910 549930 549920 860410 057750 285620 535000 218160 132060 324940 047780 004120 004130 842140 193730 193600 842160 256170 256190 842150 382410 087590 584580 805780 904960 098160 098180 941910 241310 298790 300880 300890 408260 783420 848300 899690 528130 419980 448560 465460 465440 582640 669460 589030 817000 179900 788490 092880 453280 827050 827070 149670 090400 507780 522500 119230 197000 838570 103090 694060 047390 047400 047410 588340 683450 683480 037200 003870 869160 009630 209340 130810 399780 442740 425020 494290 494300 053330 785350 302010 545270 780360 780400 977760 970270 829750 222760 430770 671900 928740 860460 057730 203030 203040 427270 520000 829600 063830 064580 006930 991750 487720 227890 224470 626900 464300 964110 983020 184550 239200 783270 783290 403570 364850 054110 054160 960050 009820 438200 401880 408150 781210 763830 763790 544580 369920 537340 811220 811320 963080 958520 126020 197000 195230 489320 489590 489830 490700 490840 503260 503710 398840 677530 099100 501430 544030 725100 997570 997560 975970 418720 481160 280200 122050 276260…
Reason for recall
Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue.
FDA-determined cause: Environmental control
Action taken
On September 11, 2019, the firm began notifying distributors and customers of the recall via an Urgent Medical Device Recall letter. The letter informed consignees of the product issue. Customers were asked to assist their Zimmer Biomet sales representative and quarantine all identified product. The sales representative will remove the product from your facility. If any products were further distributed, please forward the notification to responsible parties. If you have further questions or concerns, please call customer service at 574-371-3071 between 8:00 am and 5:00 pm ET, Monday through Friday. Calls received outside of call center operating hours will receive a voicemail prompt or be transferred to an on-call representative in the event of an emergency. Alternatively, your questions may be emailed to CorporateQuality.PostMarket@zimmerbiomet.com. There are no specific patient monitoring instructions related to this recall that are recommended beyond your existing follow-up schedule.
Details
- Recall number
- Z-0526-2020
- Initiated
- August 21, 2019
- Terminated
- July 21, 2021
- Quantity
- 219988 units (total)
- Distribution
- 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.
- Recalling firm
- Zimmer Biomet, Inc., Warsaw, IN
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0519-2020 Class II | Compress, Mini Compress; Item Nos. 178350 178351 178352 178353 178354 178355 178356…Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue. | 08/21/2019Terminated |
| Z-0520-2020 Class II | COMP RVRS Shoulder Baseplates, including Custom Products, Item numbers 115331S 115331…Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue. | 08/21/2019Terminated |
| Z-0521-2020 Class II | ACROMIUM FLANGE SET (Custom product) Item No. PM555148 - Product Usage: Arcomium…Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue. | 08/21/2019Terminated |
| Z-0522-2020 Class II | HENNESSY LEFT CONST GLENOID HA, Item No. PM555360 UDI (01)00880304819597(17)260425(10)664…Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue. | 08/21/2019Terminated |
| Z-0523-2020 Class II | Various Hip systems, Item Nos. 104207 104212 104215 11-162809 11-162810 11-162811…Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue. | 08/21/2019Terminated |
| Z-0524-2020 Class II | Comprehensive HHR Tess Cleat, Item Nos. 110260 110261 110262 110263 Product Usage: N/AElevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue. | 08/21/2019Terminated |
| Z-0525-2020 Class II | Comprehensive RS Cleat CAP, Item No. 110300Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue. | 08/21/2019Terminated |
| Z-0527-2020 Class II | Copeland HA Resurfacing Head, MB/HA EAS Head; Item Nos. 11-114641 11-114642 11-114643…Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue. | 08/21/2019Terminated |
| Z-0528-2020 Class II | HA Pins (DFS HA Cort Screw), Hoffman/Colles Pins (Colles CSER Sterile w/ Pin Kit) Item…Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue. | 08/21/2019Terminated |
| Z-0529-2020 Class II | GUIDE WIRE 2.2MM X 28IN, Aim/Art Guide wire, Item No. 809222028 - Product Usage: These…Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue. | 08/21/2019Terminated |
| Z-0530-2020 Class II | BALL NOSE GUIDE WIRE 80CM, 100CM. Item Nos. 281001080 281001100 Product Usage: These…Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue. | 08/21/2019Terminated |
| Z-0531-2020 Class II | 2.0MM BALL NOSE GUIDE WIRE, Item Nos. 281017006 - Product Usage: These instruments and…Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue. | 08/21/2019Terminated |
| Z-0532-2020 Class II | LT DISC ULNA - HA/PC; RT DISC ULNA - HA/PC; LT DISC HMRL- HA/PC; RT DISC HMRL- HA/PC…Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue. | 08/21/2019Terminated |
| Z-0533-2020 Class II | BIOMOD PORCOAT HA GLENTRAY; Custom Shoulder Products Item Nos. PM0000097 PM555140…Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue. | 08/21/2019Terminated |