{"recall":{"id":"fda-device-99883","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA device enforcement)","cat":"medicines","kids":false,"kind":"device","title":"Howmedica Osteonics Corp. recalls 4 products","firm":"Howmedica Osteonics Corp.","date":"2026-09-16","reported":"2026-10-21","status":"Ongoing","classification":"Class II","products":[{"name":"TS Universal Baseplate Finishing Tray, Triathlon. Catalog Number: 6543-6-506.","code":"Catalog Number: 6543-6-506. GTIN: 07613327548082. All lot numbers used prior to the correction date of May 8, 2026 are impacted.","quantity":"605 trays","number":"Z-0164-2027","classification":"Class II"},{"name":"TS Femoral Prep Tray, Triathlon. Catalog Number: 6543-6-507.","code":"Catalog Number: 6543-6-507. GTIN: 07613327557138. All lot numbers used prior to the correction date of May 8, 2026 are impacted.","quantity":"582 trays","number":"Z-0165-2027","classification":"Class II"},{"name":"Triathlon Hinge Femoral Prep Tray. Catalog Number: 6543-6-514.","code":"Catalog Number: 6543-6-514. GTIN: 07613327562859. All lot numbers used prior to the correction date of May 8, 2026 are impacted.","quantity":"359 trays","number":"Z-0166-2027","classification":"Class II"},{"name":"TS Misc. Instruments Tray, Triathlon. Catalog Number: 6543-6-519.","code":"Catalog Number: 6543-6-519. GTIN: 07613327555127. All lot numbers used prior to the correction date of May 8, 2026 are impacted.","quantity":"577 trays","number":"Z-0167-2027","classification":"Class II"}],"reason":"Reprocessing instructions provided in LSTPI-B specify a sterilization dry time of 30 minutes for the trays sterilized in blue wrap. When blue wrap is used, the 30-minute dry time may lead to a small amount of residual moisture remaining after sterilization.","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"These trays are provided by sale or loan. Loans are provided through Distributor. Foreign Consignees will be identified by the countries impacted. 158 trays have been distributed OUS.","nationwide":false,"states":[],"units":"605 trays; 582 trays; 359 trays; 577 trays","remedy":"","whatToDo":"Check your product against the names and codes above. The FDA enforcement record lists the recall as voluntary: firm initiated; it does not state a consumer remedy, so follow the firm’s notice or the FDA link.","contact":"","url":"https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99883","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"0a1cd201960a0114","firstSeen":"2026-11-02T13:57:14.206Z","updatedAt":"2026-11-02T13:57:14.206Z","history":[]},"official":{"fetchedAt":"2026-11-02T13:57:14.206Z","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","officialUrl":"https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99883","record":[{"status":"Ongoing","city":"Mahwah","state":"NJ","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99883","recalling_firm":"Howmedica Osteonics Corp.","address_1":"325 Corporate Dr","address_2":"","postal_code":"07430-2006","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"These trays are provided by sale or loan. Loans are provided through Distributor. Foreign Consignees will be identified by the countries impacted. 158 trays have been distributed OUS.","recall_number":"Z-0164-2027","product_description":"TS Universal Baseplate Finishing Tray, Triathlon. Catalog Number: 6543-6-506.","product_quantity":"605 trays","reason_for_recall":"Reprocessing instructions provided in LSTPI-B specify a sterilization dry time of 30 minutes for the trays sterilized in blue wrap. When blue wrap is used, the 30-minute dry time may lead to a small amount of residual moisture remaining after sterilization.","recall_initiation_date":"20260916","center_classification_date":"20261015","report_date":"20261021","code_info":"Catalog Number: 6543-6-506. GTIN: 07613327548082. All lot numbers used prior to the correction date of May 8, 2026 are impacted.","more_code_info":""},{"status":"Ongoing","city":"Mahwah","state":"NJ","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99883","recalling_firm":"Howmedica Osteonics Corp.","address_1":"325 Corporate Dr","address_2":"","postal_code":"07430-2006","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"These trays are provided by sale or loan. Loans are provided through Distributor. Foreign Consignees will be identified by the countries impacted. 158 trays have been distributed OUS.","recall_number":"Z-0165-2027","product_description":"TS Femoral Prep Tray, Triathlon. Catalog Number: 6543-6-507.","product_quantity":"582 trays","reason_for_recall":"Reprocessing instructions provided in LSTPI-B specify a sterilization dry time of 30 minutes for the trays sterilized in blue wrap. When blue wrap is used, the 30-minute dry time may lead to a small amount of residual moisture remaining after sterilization.","recall_initiation_date":"20260916","center_classification_date":"20261015","report_date":"20261021","code_info":"Catalog Number: 6543-6-507. GTIN: 07613327557138. All lot numbers used prior to the correction date of May 8, 2026 are impacted.","more_code_info":""},{"status":"Ongoing","city":"Mahwah","state":"NJ","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99883","recalling_firm":"Howmedica Osteonics Corp.","address_1":"325 Corporate Dr","address_2":"","postal_code":"07430-2006","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"These trays are provided by sale or loan. Loans are provided through Distributor. Foreign Consignees will be identified by the countries impacted. 158 trays have been distributed OUS.","recall_number":"Z-0166-2027","product_description":"Triathlon Hinge Femoral Prep Tray. Catalog Number: 6543-6-514.","product_quantity":"359 trays","reason_for_recall":"Reprocessing instructions provided in LSTPI-B specify a sterilization dry time of 30 minutes for the trays sterilized in blue wrap. When blue wrap is used, the 30-minute dry time may lead to a small amount of residual moisture remaining after sterilization.","recall_initiation_date":"20260916","center_classification_date":"20261015","report_date":"20261021","code_info":"Catalog Number: 6543-6-514. GTIN:  07613327562859. All lot numbers used prior to the correction date of May 8, 2026 are impacted.","more_code_info":""},{"status":"Ongoing","city":"Mahwah","state":"NJ","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99883","recalling_firm":"Howmedica Osteonics Corp.","address_1":"325 Corporate Dr","address_2":"","postal_code":"07430-2006","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"These trays are provided by sale or loan. Loans are provided through Distributor. Foreign Consignees will be identified by the countries impacted. 158 trays have been distributed OUS.","recall_number":"Z-0167-2027","product_description":"TS Misc. Instruments Tray, Triathlon. Catalog Number: 6543-6-519.","product_quantity":"577 trays","reason_for_recall":"Reprocessing instructions provided in LSTPI-B specify a sterilization dry time of 30 minutes for the trays sterilized in blue wrap. When blue wrap is used, the 30-minute dry time may lead to a small amount of residual moisture remaining after sterilization.","recall_initiation_date":"20260916","center_classification_date":"20261015","report_date":"20261021","code_info":"Catalog Number: 6543-6-519. GTIN: 07613327555127. All lot numbers used prior to the correction date of May 8, 2026 are impacted.","more_code_info":""}]}}