Class 2 Device Recall Compress; Mini Compress

• Date Initiated by Firm: August 21, 2019
• Create Date: November 22, 2019
• Recall Status: Terminated on July 21, 2021
• Recall Number: Z-0519-2020
• Recall Event ID: 83783
• 510(K)Number: K062998 K112905
• Product Classification: Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented - Product Code KWY
• Product: Compress, Mini Compress; Item Nos. 178350; 178351; 178352; 178353; 178354; 178355; 178356; 178357; 178358; 178359; 178360; 178361; 178362; 178363; 178364; 178365; 178366; 178367; 178368; 178369; 178370; 178371; 178372; 178373; 178464; 178472; 178480; 178488; 178496; 178504; 178575; 178576; 178577; 178578; 178579; 178580; 178730; 178731; 178732; 178733; 178734; 178735; 178354S; 178754; 178755; 178756; 178757; 178758; 178759; ; Product Usage: 1) Correction of revision of unsuccessful osteotomy, arthrodesis or previous joint replacement 2) Tumor resections 3) Revision of previously failed total joint arthroplasty 4) Trauma The ComPreSs Distal Femoral Replacement System is intended for uncemented use.
• Code Information: All lots manufactured between January 2008 - May 2019: 043240 073900 150190 236460 313350 391940 454660 460760 482880 498540 512280 544320 545330 633210 670360 762790 792260 792270 817590 921680 985030 985860 008330 008330R 107310 156490 181250 281130 310670 402480 501260 545340 545350 549190 678780 679390 720050 720060 755070 791580 816580 825010 954670 985290 989140 001130 039840 046290 114960 133540 157890 167740 177680 181260 199190 238670 242920 269770 281220 310920 428030 451480 465720 510770 510900 599300 696350 792280 821150 829820 830280 859420 921610 927330 947420 953480 010170 025880 046300 097120 133560 134450 157900 160130 177720 199200 206870 242580 281230 292790 310930 322360 349010 398080 428060 445800 445800R 477570 483190 495580 523750 588500 594850 599390 600450 615330 661100 696360 699090 715650 725930 730880 735850 794270 805190 821160 821960 836980 848500 864780 913390 925600 932080 932110 940500 947430 953490 953500 956980 958300 970180 993510 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• Recalling Firm/ Manufacturer: Zimmer Biomet, Inc.; 56 E Bell Dr; Warsaw IN 46582-6989
• 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: 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: 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.
• Total Product Life Cycle: TPLC Device Report

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.

• 510(K) Database: 510(K)s with Product Code = KWY and Original Applicant = BIOMET MANUFACTURING CORP.; 510(K)s with Product Code = KWY and Original Applicant = BIOMET ORTHOPEDICS LLC.