| Class 2 Device Recall BIOMOD | |
Date Initiated by Firm | August 21, 2019 |
Create Date | November 22, 2019 |
Recall Status1 |
Terminated 3 on July 21, 2021 |
Recall Number | Z-0533-2020 |
Recall Event ID |
83783 |
510(K)Number | K043100 |
Product Classification |
Prosthesis, shoulder, semi-constrained, metal/polymer, uncemented - Product Code MBF
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Product | BIOMOD PORCOAT HA GLENTRAY; Custom Shoulder Products
Item Nos. PM0000097
PM555140
PM555147
PM555319
PM555418
113867
113865
113863
Product Usage: Total Shoulder Replacement |
Code Information |
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 |
Recalling Firm/ Manufacturer |
Zimmer Biomet, Inc. 56 E Bell Dr Warsaw IN 46582-6989
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For Additional Information Contact | 411 Technical Services 574-371-3071 |
Manufacturer Reason for Recall | Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue. |
FDA Determined Cause 2 | 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 in Commerce | 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. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = MBF
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