Recall Z-0520-2020

Zimmer Biomet, Inc. · initiated August 21, 2019

Class II Terminated

Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature

Product

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)094500 (01)00880304475342(17)220328(10)856620 (01)00880304475342(17)220528(10)487710 (01)00880304475342(17)220628(10)028860 (01)00880304475342(17)220628(10)028870 (01)00880304475342(17)220628(10)799030 (01)00880304475342(17)220628(10)799070 (01)00880304475342(17)220628(10)929900 (01)00880304532465(17)220628(10)850060 (01)00880304475342(17)220628(10)803010 (01)00880304532465(17)220728(10)026780 (01)00880304475342(17)220828(10)208370 (01)00880304475342(17)220901(10)811210R (01)00880304475342(17)221028(10)960160 (01)00880304532465(17)221028(10)943820 (01)00880304475342(17)240616(10)237420 (01)00880304475342(17)230909(10)500790 (01)00880304475342(17)221128(10)469390 (01)00880304475342(17)221128(10)864610 (01)00880304532465(17)221128(10)234970 (01)00880304475342(17)221204(10)038140 (01)00880304475342(17)221212(10)630530 (01)00880304475342(17)221212(10)508750 (01)00880304475342(17)221212(10)769380 (01)00880304475342(17)221213(10)801090 (01)00880304475342(17)221213(10)831150 (01)00880304475342(17)221217(10)812790 (01)00880304475342(17)221218(10)543530 (01)00880304475342(17)221219(10)630010 (01)00880304532465(17)221228(10)458650 (01)00880304532465(17)221228(10)752440 (01)00880304532465(17)221228(10)786080 (01)00880304475342(17)230103(10)913540 (01)00880304475342(17)230103(10)628460 (01)00880304475342(17)230103(10)250450 (01)00880304475342(17)230104(10)913530 (01)00880304475342(17)230104(10)994010 (01)00880304475342(17)230107(10)591420 (01)00880304475342(17)230107(10)913550 (01)00880304475342(17)230108(10)732010 (01)00880304475342(17)230111(10)913570 (01)00880304475342(17)230111(10)035570 (01)00880304475342(17)230114(10)918370 (01)00880304475342(17)230117(10)042060 (01)00880304475342(17)230118(10)042100 (01)00880304475342(17)230118(10)014090 (01)00880304475342(17)230121(10)014110 (01)00880304475342(17)230124(10)081050 (01)00880304475342(17)230128(10)967360 (01)00880304532465(17)230128(10)014050 (01)00880304475342(17)230129(10)967280 (01)00880304475342(17)230204(10)913560 (01)00880304475342(17)230205(10)460190 (01)00880304475342(17)230205(10)207400 (01)00880304475342(17)230206(10)081040 (01)00880304532465(17)230207(10)014060 (01)00880304475342(17)230207(10)081030 (01)00880304532465(17)230207(10)843610 (01)00880304532465(17)230207(10)319470 (01)00880304475342(17)230207(10)081060 (01)00880304475342(17)230207(10)274520 (01)00880304475342(17)230208(10)165560 (01)00880304532465(17)230208(10)165530 (01)00880304475342(17)230211(10)165570 (01)00880304532465(17)230211(10)207450 (01)00880304532465(17)230211(10)520910 (01)00880304532465(17)230214(10)112280 (01)00880304475342(17)230214(10)460470 (01)00880304532465(17)230214(10)555280 (01)00880304532465(17)230214(10)173830 (01)00880304532465(17)230215(10)014040 (01)00880304532465(17)230215(10)387150 (01)00880304475342(17)230215(10)165550 (01)00880304475342(17)230215(10)207430 (01)00880304475342(17)230215(10)319510 (01)00880304532465(17)230215(10)512310 (01)00880304532465(17)230215(10)124710 (01)00880304532465(17)230215(10)274460 (01)00880304532465(17)230215(10)322260 (01)00880304532465(17)230215(10)562180 (01)00880304532465(17)230215(10)006420 (01)00880304532465(17)230218(10)319480 (01)00880304475342(17)230218(10)433460 (01)00880304532465(17)230219(10)433400 (01)00880304475342(17)230219(10)319500 (01)00880304532465(17)230219(10)487040 (01)00880304532465(17)230219(10)491250 (01)00880304475342(17)230220(10)446680 (01)00880304532465(17)230220(10)433430 (01)00880304532465(17)230221(10)446660 (01)00880304532465(17)230222(10)433380 (01)00880304475342(17)230222(10)594640 (01)00880304532465(17)230225(1

Codes / lots: 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…

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-0520-2020
Initiated
August 21, 2019
Terminated
July 21, 2021
Product code
KWS – Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Quantity
219988 units
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

Official FDA recall record

Other products in the same recall event

RecallProductInitiated
Z-0519-2020 Class IICompress, 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-0521-2020 Class IIACROMIUM 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 IIHENNESSY 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 IIVarious 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 IIComprehensive 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 IIComprehensive 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-0526-2020 Class IIVarious Custom Products, Item Nos. CP102940 CP102941 CP102942 CP102943 CP102944 CP102945…Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue. 08/21/2019Terminated
Z-0527-2020 Class IICopeland 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 IIHA 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 IIGUIDE 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 IIBALL 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 II2.0MM 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 IILT 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 IIBIOMOD 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