Reported Dec 4, 2019 · Terminated

BIOMOD PORCOAT HA GLENTRAY; Custom Shoulder Products Item Nos. PM0000097 PM555140 PM555147 PM555319 PM555418 113867…

Zimmer Biomet, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Zimmer Biomet, Inc. · 56 E Bell Dr · Warsaw, IN · 46582-6989

Is this the product you have?

BIOMOD PORCOAT HA GLENTRAY; Custom Shoulder Products Item Nos.
- PM0000097
- PM555140
- PM555147
- PM555319
- PM555418
- 113867
- 113865
- 113863
Product UsageTotal Shoulder Replacement

Lot codes and dates: LOTS
67 of 67 codes
584440
823130
966710
653720
191230
361690
917170
993450
009590
971720
197730
421300
970590
799740
713840
265680
924350
729030
843020
729020
034400
279060
958550
451520
040360
364420
399470
417590
446550
449550
489790
572090
587200
609410
616720
965280
975560
996130
873200
287000
951480
031170
659320
830600
297280
407350
907020
751730
641070
713850
729050
729040
960150
957220
451540
299920
564400
150450
770600
364540
UDI (01)00887868226441(17)270911(10)823130 (01)00880304804180(17)251120(10)966710 (01)00880304860001(17)270228(10)191230 (01)00880304443044(17)230220(10)265680 (01)00880304443044(17)230315(10)729030 (01)00880304443044(17)230319(10)843020 (01)00880304443044(17)230328(10)729020 (01)00880304443044(17)230430(10)034400 (01)00880304443044(17)230520(10)279060 (01)00880304443044(17)230816(10)958550 (01)00880304443044(17)240212(10)451520 (01)00880304434127(17)230319(10)729050 (01)00880304434127(17)230328(10)729040 (01)00880304434127(17)230408(10)960150 (01)00880304434127(17)230816(10)957220 (01)00880304434127(17)240221(10)451540 (01)00880304434127(17)240714(10)299920 (01)00880304434127(17)250319(10)564400 (01)00880304434127(17)250331(10)150450 (01)00880304434127(17)260118(10)770600 (01)00880304433496(17)230816(10)957590 (01)00880304433496(17)240327(10)868620 (01)00880304433496(17)240521(10)537430 (01)00880304433496(17)240612(10)810590
Amount recalled: 214741

This recall covers 16 products

The agency filed one notice per product. You are reading one of them; the other 15 are below.

3 more are in the archive.

Where it was sold

Nationwide

Why it was recalled

Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue.

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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By hazard

Medical device recalls

Other recalls from Zimmer Biomet, Inc.

84 in total.

All recall categories · Browse the whole archive