{ "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": "2026-08-13", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "104954", "product_res_number": "Z-0318-2012", "event_date_initiated": "2011-10-31", "event_date_posted": "2011-11-30", "recall_status": "Terminated", "event_date_terminated": "2015-08-05", "res_event_number": "60287", "product_code": "MAI", "k_numbers": [ "K040827", "K070925" ], "product_description": "DePuy Mitek Panalock Loop w/ Orthocord\nCatalog #222980\n\nThe LUPINE BR Anchor System is indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization.", "code_info": "Lot number 3547740; Product code: 222980", "firm_fei_number": "1221934", "recalling_firm": "DePuy Mitek, Inc., a Johnson & Johnson Co.", "address_1": "325 Paramount Dr", "city": "Raynham", "state": "MA", "postal_code": "02767", "additional_info_contact": "Same\n508-880-8100", "reason_for_recall": "Incorrect suture configuration", "root_cause_description": "Employee error", "action": "The firm, DePuy Mitek Inc., sent an \"URGENT VOLUNTARY PRODUCT RECALL\"letter dated October 31, 2011 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to not use or sell any of the identified problem products included in this recall; complete the enclosed business reply form and fax to: 1-508-828-3750 or email to: mitekcomplaints@its.jnj.com (note: It is important that we receive this business reply form, even if you have no product remaining in your inventory from the affected lots); isolate all inventory and call 1-877-379-4871 for return goods authorization and replacement product; and return all identified affected product to: (USA)- DePuy Mitek, ATTN: Recall Coordinator, 50 Scotland Boulevard, Bridgewater, MA 02324 or (foreign)-GMED Healthcare EDC Quality Dept Rue de Luxembourg 5, ZI Trazegnies, BE-6180 Courcelles, Belgium. \n\nIf you have any questions or concerns with regard to this program, please contact your local DePuy Mitek Representative or DePuy Mitek Customer Service directly at 1-877-379-4871.", "product_quantity": "295 units", "distribution_pattern": "Worldwide distribution: USA (nationwide) and countries of: Austria, Australia, Brazil, Canada, Estonia,Switzerland, China, Czechoslovakia, Denmark, Spain, Finland, France, Great Britain Israel, India, Japan, Korea, Mexico, Martinique, Norway, Portugal, Sweden, Singapore, Solvonia, and Slovakia.", "openfda": { "k_number": [ "K973381", "K180101", "K993373", "K201749", "K051250", "K990987", "K203523", "K031519", "K031981", "K041307", "K003984", "K170501", "K955486", "K181809", "K973849", "K093844", "K101459", "K143660", "K943249", "K990999", "K032197", "K170639", "K180768", "K993073", "K254055", "K053492", "K251309", "K993061", "K250526", "K955003", "K210122", "K250528", "K002406", "K161174", "K091041", "K990361", "K171228", "K071456", "K151342", "K974876", "K142948", "K200725", "K180960", "K212912", "K052799", "K120540", "K100012", "K103309", "K051219", "K222263", "K181746", "K203334", "K964521", "K130917", "K991715", "K180594", "K982900", "K101823", "K221099", "K213415", "K112040", "K993074", "K991009", "K963369", 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