Class 2 Device Recall Copeland HA Resurfacing Head, MB/HA EAS Head

• Date Initiated by Firm: August 21, 2019
• Create Date: November 22, 2019
• Recall Status: Terminated on July 21, 2021
• Recall Number: Z-0527-2020
• Recall Event ID: 83783
• 510(K)Number: K010635 K051843 K010827
• Product Classification: Prosthesis, shoulder, semi-constrained, metal/polymer, uncemented - Product Code MBF
• Product: Copeland HA Resurfacing Head, MB/HA EAS Head; Item Nos. 11-114641; 11-114642; 11-114643; 11-114644; 11-114644S; 11-114645; 11-114646; 11-114647; 11-114648; 11-114661; 11-114662; 11-114663; 11-114664; 11-114664S; 11-114665; 11-114666; 11-114667; 11-114668; 11-114632; 11-114633; Product Usage: Partial Shoulder Replacement.
• Code Information: All lots manufactured between January 2008 - May 2019: 197000 838570 047410 869160 047400 047390 203030 203040 224470 482850 052950 076580 917420 326610 362350 565380 374150 420170 374160 882210 882090 746150 691040 969190 942350 726180 048880 385080 111310 013150 868010 638680 745730 780270 780240 013140 834290 623340 817490 028380 186120 409420 847030 679990 755600 409330 706270 169490 936000 400990 343410 235880 917410 872790 715870 179470 313330 324140 362650 305750 326590 920210 564070 305740 632120 684640 536380 564770 014640R 745910 629320 629350 014640 807570 946770 111280 946800 735450 108390 370610 385070 884110 013160 884080 621660 919220 836010 645380 706600 899340 712500 838730 963630 021010 896300 673910 669190 146510 613110 678830 335900 684340 106100 105780 140000 447810 154700 911280 363670 102500 931980 519820 114830 762310 076570 296510 917390 096130 059170 362810 552990 684260 587040 565220 484880 634740 485340 414520 906620 808780 678310 969290 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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 (total)
• 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 = MBF and Original Applicant = BIOMET ORTHOPEDICS, INC.; 510(K)s with Product Code = MBF and Original Applicant = BIOMET, INC.