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

Class I - Dangerous

🏥 Medical Devices Recalled: August 21, 2019 Zimmer Biomet Other Medical Devices Nationwide

What Should You Do?

Check if you have this product:
LOTS 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 146250 761320 957590 868620 537430 810590 364560 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
Do not eat it: Even if it looks and smells fine, do not consume this product.
Throw it away or return it: You can return the product to the store for a full refund.
Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:: Zimmer Biomet, Inc.
Reason for Recall:: Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue.
Classification:: Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
Status:: terminated

Product Information

Full Description:

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

Product Codes/Lot Numbers:

LOTS 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 146250 761320 957590 868620 537430 810590 364560 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

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0533-2020

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