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

Recall number

Z-0533-2020

Recalling firm

Zimmer Biomet, Inc.

Product

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

Status

Terminated

Initiated

2019-08-21

Posted

not on file

Terminated

2021-07-21

Reason

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

Root cause

Environmental control

Action

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.

Quantity

214741

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.

Lot, serial or model codes

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

510(k) numbers

["K043100"]

PMA numbers

not on file

Product code

MBF

Firm FEI

1825034

Firm city

Warsaw

Firm state

IN

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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