{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-08-15", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "203293", "product_res_number": "Z-0069-2024", "event_date_initiated": "2023-09-05", "event_date_posted": "2023-10-06", "recall_status": "Open, Classified", "res_event_number": "93021", "product_code": "GFD", "product_description": "Zimmer Dermatome Blades- 10-pack boxes of blades. Intended for use with the dermatome handpiece which is a skin grafting instrument that is intended to provide variable graft thickness and width capabilities\nPart number: 00880000010", "code_info": "FG (Blade) UDI:\n(01)00889024375895(17)280205(10)65599469\n(01)00889024375895(17)280206(10)65620875\n(01)00889024375895(17)280207(10)65621233\n(01)00889024375895(17)280209(10)65630969\n(01)00889024375895(17)280212(10)65647382\n(01)00889024375895(17)280213(10)65648460\n(01)00889024375895(17)280214(10)65709066\n(01)00889024375895(17)280219(10)65925347\n(01)00889024375895(17)280220(10)65925348\n(01)00889024375895(17)280221(10)65935737\n(01)00889024375895(17)280223(10)65935738\n(01)00889024375895(17)280319(10)65952857\n(01)00889024375895(17)280424(10)65952858\n(01)00889024375895(17)280430(10)65972711\n(01)00889024375895(17)280503(10)65972712\n(01)00889024375895(17)280507(10)65988623\n(01)00889024375895(17)280426(10)65952862\n(01)00889024375895(17)280509(10)65988624\n(01)00889024375895(17)280514(10)65989036\n(01)00889024375895(17)280516(10)65989037\n(01)00889024375895(17)280520(10)66000975\n(01)00889024375895(17)280523(10)66000976\n(01)00889024375895(17)280528(10)66002852\n(01)00889024375895(17)280530(10)65952860\n(01)00889024375895(17)280610(10)66002853\n(01)00889024375895(17)280613(10)66014333\n(01)00889024375895(17)280617(10)66014332\n(01)00889024375895(17)280624(10)66038885\n(01)00889024375895(17)280628(10)66172214\n(01)00889024375895(17)280710(10)66049031\n(01)00889024375895(17)280724(10)66078057\n(01)00889024375895(17)280719(10)66049032\n\nSales Unit (Box) UDI\n(01)00889024380318(17)280205(10)65599469\n(01)00889024380318(17)280206(10)65620875\n(01)00889024380318(17)280207(10)65621233\n(01)00889024380318(17)280209(10)65630969\n(01)00889024380318(17)280212(10)65647382\n(01)00889024380318(17)280213(10)65648460\n(01)00889024380318(17)280214(10)65709066\n(01)00889024380318(17)280219(10)65925347\n(01)00889024380318(17)280220(10)65925348\n(01)00889024380318(17)280221(10)65935737\n(01)00889024380318(17)280223(10)65935738\n(01)00889024380318(17)280319(10)65952857\n(01)00889024380318(17)280424(10)65952858\n(01)00889024380318(17)280430(10)65972711\n(01)00889024380318(17)280503(10)65972712\n(01)00889024380318(17)280507(10)65988623\n(01)00889024380318(17)280426(10)65952862\n(01)00889024380318(17)280509(10)65988624\n(01)00889024380318(17)280514(10)65989036\n(01)00889024380318(17)280516(10)65989037\n(01)00889024380318(17)280520(10)66000975\n(01)00889024380318(17)280523(10)66000976\n(01)00889024380318(17)280528(10)66002852\n(01)00889024380318(17)280530(10)65952860\n(01)00889024380318(17)280610(10)66002853\n(01)00889024380318(17)280613(10)66014333\n(01)00889024380318(17)280617(10)66014332\n(01)00889024380318(17)280624(10)66038885\n(01)00889024380318(17)280628(10)66172214\n(01)00889024380318(17)280710(10)66049031\n(01)00889024380318(17)280724(10)66078057\n(01)00889024380318(17)280719(10)66049032\n\nLot Numbers:\n65599469\t\n65620875\t\n65621233\t\n65630969\t\n65647382\t\n65648460\t\n65709066\t\n65925347\t\n65925348\t\n65935737\t\n65935738\t\n65952857\t\n65952858\t\n65972711\t\n65972712\t\n65988623\t\n65952862\t\n65988624\t\n65989036\t\n65989037\t\n66000975\t\n66000976\t\n66002852\t\n65952860\t\n66002853\t\n66014333\t\n66014332\t\n66038885\t\n66172214\t\n66049031\t\n66078057\t\n66049032", "firm_fei_number": "1526350", "recalling_firm": "Zimmer Surgical Inc", "address_1": "200 W Ohio Ave", "city": "Dover", "state": "OH", "postal_code": "44622-9642", "additional_info_contact": "411 Technical Services\n574-371-3071", "reason_for_recall": "Skin grafts thin and non-uniform when using the affected blades. The issue would be identified at the time of use and may result in the need for additional harvests to adequately cover the area", "root_cause_description": "Process control", "action": "Zimmer issued Urgent Medical Device Recall Letter (FA 2023-00208 ) to Distributors and \nRisk Managers and Recall FAQs to affected consignees on September 5, 2023. Letter states reason for recall, health risk and action to take:\n1. Review this notification and ensure that affected personnel are aware of the contents.\n2. If you have affected product at your facility, immediately locate and quarantine affected product in your inventory.\na. Your Zimmer Biomet sales representative may remove and return the affected product from your facility on your behalf.\nb. Alternatively, you may directly return all affected product from your facility.\ni. Complete Attachment 1 Certificate of Acknowledgement for each return and send to CorporateQuality.PostMarket@zimmerbiomet.com.\nii. Include a hardcopy of Attachment 1 in each carton of your return shipment for immediate processing.\niii. Mark RECALL on the outside of the returned cartons\n3. If the product has been further distributed, provide your customers with the recall notice and ensure documentation.\n4. Complete Attachment 1 Certificate of Acknowledgement and send to CorporateQuality.PostMarket@zimmerbiomet.com. This form shall be returned even if you do not have affected products at your facility. Upon receipt of affected product, Zimmer Biomet will credit your account. Please return a copy of the completed response form along with your returned product to ensure proper credit.\n5. Retain a copy of the acknowledgement form with your recall records in the event of a compliance audit of your facility s documentation.\n6. If you have further questions or concerns after reviewing this notice, please call customer service at 574-371-3071 between 8:00 am and 5:00pm EST, 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@zimm", "product_quantity": "11,985 boxes (119,850 blades)", "distribution_pattern": "US Nationwide\nForeign: \nAUSTRALIA\nBRAZIL\nCHINA\nHONG KONG\nINDIA\nJAPAN\nMALAYSIA\nMEXICO\nNETHERLANDS\nON\nSEOUL\nSINGAPORE\nTAIWAN\nTHAILAND", "openfda": { "k_number": [ "K951085", "K962371", "K861138", "K965256", "K860925", "K861285", "K792332", "K862669", "K940208", "K842702", "K945594", "K830993" ], "registration_number": [ "1424263", "9680741", "3007751444", "3005205318", "3015136927", "3008770252", "1526534", "9610612", "3011547157", "3013784566", "3009518429", "3003418325", "3012226300", "2084346", "9680718", "3003244954", "8043750", "1319639", "9611484", "3007648354", "1836161", "3002807314", "9680890", "9611503", "3007773213", "3016069968", "3011981870", "3014328942", "3008950755", "1219518", "3022320321", "3005695724", "3009513193", "3030733800", "3004112621", "1722447", "9611283", "3002808145", "9680411", "3013901429", "2916714", "8040278", "9611274", "3026264", "3023657851", "1822565", "8030607", "3002808022", "3011554142", "1018233", "3010402752", "3004608878", "3010687973", "3013557562", "3009039068", "3012366928", "1058584", "3008808560", "3016678045", "3018784829", "3035678069", "3018068202", "1222274", "1421879", "2029275", "3003587896", "1054811", "3023244395", "3007137643", "1526350", "3013273457", "3009736547" ], "fei_number": [ "3002750084", "3007751444", "3005205318", "3015136927", "3008770252", "1000219637", "1526534", "3011547157", "3013784566", "3006509795", "1000124817", "3009518429", "3003418325", "3012226300", "3003244954", "3002808335", "3007648354", "3008205331", "1000126561", "3002807314", "3007773213", "3016069968", "3011981870", "3014328942", "3008950755", "1219518", "3022320321", "3005695724", "3009513193", "3030733800", "3004601847", "3004112621", "1000121057", "3002808145", "1000138491", "3008501922", "3013901429", "2916714", "3023657851", "3002806315", "1000138054", "1000114185", "3002808043", "3002808022", "3011554142", "1018233", "3010402752", "3004608878", "3010687973", "3013557562", "3009039068", "3012366928", "3016678045", "1000115048", "3018784829", "3002807390", "3035678069", "1000220733", "3018068202", "1000306431", "3003015552", "3003587896", "3002948288", "3000280067", "3005601686", "3023244395", "3007137643", "3004216008", "1526350", "3013273457", "3009736547", "3002806816" ], "device_name": "Dermatome", "medical_specialty_description": "General, Plastic Surgery", "regulation_number": "878.4820", "device_class": "1" } } ] }