{ "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": "2026-08-27", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "205269", "product_res_number": "Z-0773-2024", "event_date_initiated": "2024-01-03", "event_date_posted": "2024-01-19", "recall_status": "Open, Classified", "res_event_number": "93709", "product_code": "PHX", "k_numbers": [ "K183696" ], "product_description": "Stryker Tornier Perform Reversed Glenoid Press-Fit Short Post Ti6AI4V, REF DWJ001, L: 7mm, Cementless Sterile.", "code_info": "Batch lot codes 6714AZ, serial numbers 001 to 050: 6714AZ001, 6714AZ002, 6714AZ003, 6714AZ004, 6714AZ005, 6714AZ006, 6714AZ007, 6714AZ008, 6714AZ009, 6714AZ010, 6714AZ011, 6714AZ012, 6714AZ013, 6714AZ014, 6714AZ015, 6714AZ016, 6714AZ017, 6714AZ018, 6714AZ019, 6714AZ020, 6714AZ021, 6714AZ022, 6714AZ023, 6714AZ024, 6714AZ025, 6714AZ026, 6714AZ027, 6714AZ028, 6714AZ029, 6714AZ030, 6714AZ031, 6714AZ032, 6714AZ033, 6714AZ034, 6714AZ035, 6714AZ036, 6714AZ037, 6714AZ038, 6714AZ039, 6714AZ040, 6714AZ041, 6714AZ042, 6714AZ043, 6714AZ044, 6714AZ045, 6714AZ046, 6714AZ047, 6714AZ048, 6714AZ049, 6714AZ050; GTIN 00846832091614.", "firm_fei_number": "3000718467", "recalling_firm": "Tornier, Inc", "address_1": "10801 Nesbitt Ave S", "city": "Bloomington", "state": "MN", "postal_code": "55437-3109", "additional_info_contact": "Meghan Wells\n901-201-9298", "reason_for_recall": "The incorrect device is contained in the labeled package.", "root_cause_description": "Packaging process control", "action": "The recalling firm issued letters dated 1/3/2024 via email to sales representatives and distributors and via FedEx to hospitals on 1/3/2024. The letter provided a product description, product issue, potential risks including a photo of the device that should be in the package and a photo of the device that was in the package. The customer actions needed included: (1) Immediately check the inventory for the affected product, remove it from the point of use, and isolate/quarantine it to prevent accidental use; (2) Sign and return the enclosed Business Reply Form by email to confirm receipt of the notification; (3) Upon receipt of the completed Business Reply Form, the firm will contact the customer to arrange for return of the product; (4) If the product has been further distributed, notify the applicable parties at once about the recall. If possible, inform the recalling firm if any of the devices have been distributed to other organizations, including contact details. If the letter recipient is a distributor, they are responsible for notifying their affected customers.", "product_quantity": "50", "distribution_pattern": "Distribution was made to AR, AZ, CA, CO, CT, NC, OH, TN, and VA. 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