Class 2 Device Recall DFS, Hoffman/Colles

• Date Initiated by Firm: August 21, 2019
• Create Date: November 22, 2019
• Recall Status: Terminated on July 21, 2021
• Recall Number: Z-0528-2020
• Recall Event ID: 83783
• 510(K)Number: K081244 K992367 K003397 K013503
• Product Classification: Appliance, fixation, nail/blade/plate combination, multiple component - Product Code KTT
• Product: HA Pins (DFS HA Cort Screw), Hoffman/Colles Pins (Colles CSER Sterile w/ Pin Kit); ; Item Nos: HAA60-09030; HAA60-09040; HAA60-10030; HAA60-10040; HAA60-11030; HAA60-11040; HAA60-11050; HAA60-12040; HAA60-12060; HAA60-13030; HAA60-13040; HAA60-13050; HAA60-13060; HAA60-13070; HAA60-14050; HAA60-14080; HAA60-14090; HAA60-15020; HAA60-15030; HAA60-15040; HAA60-15050; HAA60-15060; HAA60-16030; HAA60-16040; HAA60-16050; HAA60-16070; HAA60-16090; HAA60-17040; HAA60-17060; HAA60-17080; HAA60-18010; HAA60-18030; HAA60-18040; HAA60-18050; HAA60-18060; HAA60-18090; HAA60-20030; HAA60-20040; HAA60-20050; HAA60-20060; HAA60-20080; HAA60-20090; HAA60-22050; HAA60-22060; HAA60-25030; HAA60-25040; HAA60-25050; HAA60-25060; HAA60-30060; HAB60-09030; HAB60-10030; HAB60-10040; HAB60-11040; HAB60-11050; HAB60-12040; HAB60-12060; HAB60-13040; HAB60-13050; HAB60-13060; HAB60-14050; HAB60-15060; HAB60-16070; HAB60-16090; HAB60-17080; HAB60-18010; HAB60-18090; HAB60-20080; HAB60-20090; 808200000; Product Usage: These devices are intended for osteosynthesis, external fixation of fractures or bone lengthening procedures.
• Code Information: Lots 089610 241030 089600 241020 238180 416260 507280 450740 314580 736790 779690 889140 836030 970200 444550 984630 316530 198990 419500 431591 444655 459030 633280 921380 148200 441530 718410 884690 856150 444530 066610 352090 553250 HA109-05 148190 666010 825420 989490R 989490 444510 444510R 984610 241410 390410 152390 316520 390410R 432706 484710 484720 238170 427280 450730 323210 507270 748450 789870 877610 002130 444500 984600 363080 670430 136700 198960 198970 230290 230300 413443 413444 432705 984600R 148180 441520 456560 732840 825410 889130 970190 444420 984580 921390 530950 120230 198910 198930 230280 413441 803810 803810R 086800 357830 740750 921550 450720 323200 640280 718400 856140 946100 444470 057550 386080 303010 633210 403720 516120 418870 824120 592130 148930 017430 802520 274630 966250 966260 047790 351330 822190 846490 131420 131430 912600 965370 277220 314570 450710 771080 856130R 856130 988850 251590 444450 621070 147070 530940 120220 198850 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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: 178886
• 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 = KTT and Original Applicant = BIOMET TRAUMA; 510(K)s with Product Code = KTT and Original Applicant = DEPUY ORTHOPAEDICS, INC.; 510(K)s with Product Code = KTT and Original Applicant = ELECTRO-BIOLOGY, INC.