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 CP11
Check against the official notice below — it lists the full affected range.
Zimmer Biomet, Inc. is recalling various custom orthopedic products across multiple item numbers due to elevated levels of bacterial endotoxin and residual debris remaining on the devices as a result of a cleaning issue. The recall affects 219,988 units total with distribution in the United States and 22 other countries worldwide, including Canada, Mexico, Brazil, Australia, Japan, and others. All lots manufactured between January 2008 and May 2019 are included in the recall.
The affected devices are identified by specific lot and code numbers provided in the recall notice. The source document does not specify a remedy or recommended action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue.
Reason for recall: Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue. 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. Quantity: 219988 units (total) Lot/code info: 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 278030 595380 601710 601700 601730 595820 600810 636330 648400 600600 816490 482850 281380 577580 684070 051290 015910 233430 233270 359560 566560 445750 172350 030870 247430 597870 332340 331070 490540 920450 224420 251940 191060 547260 444650 080060 251170 390910 425180 341320 993180 390900 806420
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.