COMP RVRS Shoulder Baseplates, including Custom Products, Item numbers 115331S 115331 115330S 115330 110040610 110040620 010000589 CP561861 PM0001456 PM551047 PM551063 PM555137 PM555160 PM555209 PM555322 PM555406 PM555415 UDI: (01)00880304475342(17)211128(10)704850 (01)00880304475342(17)220128(10)09
Check against the official notice below — it lists the full affected range.
Zimmer Biomet is recalling approximately 219,988 COMP RVRS Shoulder Baseplates and custom products distributed nationwide in the US and in 22 other countries. The devices have elevated levels of bacterial endotoxin and residual debris on them due to a cleaning issue during manufacturing. The affected products were manufactured between January 2008 and May 2019 and are identified by specific lot/code numbers.
The recall notice does not specify a remedy or instructions for what consumers should do.
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 Lot/code info: All lots manufactured between January 2008 - May 2019: 064270 080270 128980 137290 143730 153340 159530 167310 167350 178160 202110 204480 215370 217060 222160 222300 252860 267090 276540 276620 307580 308360 314480 343540 350100 356980 367640 384320 422970 427440 454950 497760 512310 515990 534870 549000 551140 558390 563890 574720 607950 616850 627550 627670 630310 636470 643170 653820 673480 685260 694200 699690 715590 716060 752360 762320 775690 775740 799160 799210 812890 822070 832770 832990 833090 833800 835910 836580 851290 880580 892250 914760 917410 924500 925720 929750 929920 951620 953380 957790 960130 960370 968400 969900 004360 023060 043830 045520 051210 055590 064990 095300 124710 133900 149180 160150 161960 167340 181730 187990 190220 211220 252870 268490 274460 281780 330640 349640 351240 351930 352140 356860 358350 363840 470270 474740 474930 491250 491500 520870 522390 523010 529290 535000 539710 571640 610480 619900 623270 688980 698110 699300 740680 752370 752440 777920 786080 789370 792540 799710 823190 870400 892330 895480 917430 924470 927880 929680 952270 956910 960110 011300 012720 019650 051200 052410 058980 066080 123760 134630 143340 167520 173700 185670 191120 207860 260270 268110 324460 347380 357400 376030 406600 423030 454990 477630 485320 496850 497960 529740 548340 587230 593200 636020 636500 643150 655850 686280 703180 723850 743140 775680 792530 825560 827640 830750 895670 907690 953070 071930 076970 081800 102960 167760 216010 268400 322
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.