{ "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": "177034", "product_res_number": "Z-0405-2020", "event_date_initiated": "2019-10-18", "event_date_created": "2019-11-14", "recall_status": "Terminated", "event_date_terminated": "2021-04-09", "res_event_number": "84033", "product_code": "PHX", "k_numbers": [ "K122698" ], "product_description": "Aequalis Ascend Flex Humeral Stem:\nPart Number\tUDI\nDWF601A\t3700386944475\nDWF601B\t3700386944482\nDWF601C\t3700386944499\nDWF602A\t3700386944505\nDWF602B\t3700386944512\nDWF602C\t3700386944529\nDWF603A\t3700386944536\nDWF603B\t3700386944543\nDWF603C\t3700386944550\nDWF604A\t3700386944567\nDWF604B\t3700386944574\nDWF605A\t3700386944598\nDWF605B\t3700386944604\nDWF605C\t3700386944611\nDWF606A\t3700386944628\nDWF606B\t3700386944635\nDWF606C\t3700386944642\nDWF607A\t3700386944659\nDWF607B\t3700386944666\nDWF607C\t3700386944673\nDWF608A\t3700386944680\nDWF608B\t3700386944697\nDWF608C\t3700386944703\nDWF609A\t3700386944710\nDWF609B\t3700386944727\nDWF609C\t3700386944734\nDWF611A\t3700386944741\nDWF611B\t3700386944758\nDWF611C\t3700386944765\nDWF612A\t3700386944772\nDWF612B\t3700386944789\nDWF612C\t3700386944796\nDWF613A\t3700386944802\nDWF613B\t3700386944819\nDWF613C\t3700386944826\nDWF614A\t3700386944833\nDWF614B\t3700386944840\nDWF614C\t3700386944857\nDWF615A\t3700386944864\nDWF615B\t3700386944871\nDWF615C\t3700386944888\nDWF616A\t3700386944895\nDWF616B\t3700386944901\nDWF616C\t3700386944918\nDWF617A\t3700386944925\nDWF617B\t3700386944932\nDWF617C\t3700386944949\nDWF618A\t3700386944956\nDWF618B\t3700386944963\nDWF618C\t3700386944970\nDWF619A\t3700386944987\nDWF619B\t3700386944994\nDWF619C\t3700386945007\nDWF702A\t3700386945045\nDWF702B\t3700386945052\nDWF702C\t3700386945069\nDWF703A\t3700386945076\nDWF703B\t3700386945083\nDWF703C\t3700386945090\nDWF704A\t3700386945106\nDWF704B\t3700386945113\nDWF704C\t3700386945120\nDWF705A\t3700386945137\nDWF705B\t3700386945144\nDWF705C\t3700386945151\nDWF706A\t3700386945168\nDWF706B\t3700386945175\nDWF706C\t3700386945182\nDWF707A\t3700386945199\nDWF707B\t3700386945205\nDWF707C\t3700386945212\nDWF708A\t3700386945229\nDWF708B\t3700386945236\nDWF708C\t3700386945243\nDWF709A\t3700386945250\nDWF709B\t3700386945267\nDWF709C\t3700386945274\nDWF712A\t3700386945311\nDWF712B\t3700386945328\nDWF712C\t3700386945335\nDWF713A\t3700386945342\nDWF713B\t3700386945359\nDWF713C\t3700386945366\nDWF714A\t3700386945373\nDWF714B\t3700386945380\nDWF714C\t3700386945397\nDWF715A\t3700386945403\nDWF715B\t3700386945410\nDWF715C\t3700386945427\nDWF716A\t3700386945434\nDWF716B\t3700386945441\nDWF716C\t3700386945458\nDWF717A\t3700386945465\nDWF717B\t3700386945472\nDWF717C\t3700386945489\nDWF718A\t3700386945496\nDWF718B\t3700386945502\nDWF718C\t3700386945519\nDWF719A\t3700386945526\nDWF719B\t3700386945533\nDWF719C\t3700386945540\n\nProduct Usage: The AEQUALIS ASCEND FLEX Convertible Shoulder System is intended for use as: A replacement of shoulder joints in primary anatomic or primary reverse. A replacement of other shoulder joint devices in case of revisions, if sufficient bone stock remains. The AEQUALIS ASCEND FLEX Convertible Shoulder System also allows for conversions from anatomic to reverse shoulder prosthesis in case of revision.", "code_info": "All Lot/Serial Numbers", "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": "Darren Brown\n952-426-7625", "reason_for_recall": "During shipping, it is possible for the Aequalis Ascend Flex humeral stem to become unseated or otherwise move within its internal packaging restraints. Movement within the packaging may cause the product to rub against the PETG blister shipping container causing the transfer of PETG material from the blister container to the stem.", "root_cause_description": "Package design/selection", "action": "The firm notified their consignees by letter on 10/18/2019. The notices explained the issue and requested the following:\nPlease undertake the following urgent actions when using Aequalis Ascend Flex humeral stems: \n\" Ensure backup stem product is available in the operating room or is easily accessible prior to beginning surgery. \n\" Visually examine the stem after removing the stem from its packaging. \n\" If white film or particles are seen on the stem as pictured in Attachment A, immediately remove the implant and anything it touches from the sterile field. Replace the stem with a backup stem that lacks visible white film or particles.\n\" If no packaging material is visible on the stem, you may proceed with the implantation procedure. \n\" Report the discovery of any stems with packaging material to Wright Medical.\n\" Contact customer service to facilitate the return and replacement of any affected product \n o\tCustomer Service Customer.service@Wright.com, or 1-888-494-7950\n o\tReturn product to Wright Medical, 10801 Nesbitt Ave S, Bloomington, MN 55437\n o\tPlease identify that this product and issue is related to Field Action FA-WMG-2019-005\nPlease contact the following for information:\n\tCustomer service Customer.service@Wright.com (replacements, product support)\n\tField Action Team FieldAction@Wright.com (more information on this notice)\n\tComplaints Team Complaints-US@Wright.com (If product is found to be non-conforming)", "product_quantity": "87869 units", "distribution_pattern": "US Nationwide distribution.", "openfda": { 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