--- title: "Osteomed, LLC Recalls: Agency-Reported Status and History (Oct 1, 2026) | Is It on Recall" description: "Search Osteomed, LLC recall records, lots, firms and dates. Reported status can be incomplete; use the linked agency notice for current instructions." url: https://isitonrecall.com/brand/osteomed-llc/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Home](https://isitonrecall.com/) / Brand archive # Osteomed, LLC recall records **3** reported ongoing 3 records in this archive. Latest source date May 31, 2023. FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination. Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/). ## Records and reported status May 31, 2023 FDA device enforcement ### [REF: 218-1604, 1.6mm x 4mm Profile Zero Auto-Drive Screw, Rx Only, Sterile](https://isitonrecall.com/recall/fda-device-z-2107-2023-ref-218-1604-1-6mm-x-4mm-profile-zero-auto-drive-screw-rx-only-sterile/) Screws for osteotomies have contain an undersize screwhead which has the potential to pass through the plate hole. Class II Reported ongoing Distribution: Worldwide - US Nationwide distribution in the states of AZ, CA, FL, GA, KS, KY, MD, MO, MT, NE, NY, TN, TX and the country of SG. [Official source for REF: 218-1604, 1.6mm x 4mm Profile Zero Auto-Drive Screw, Rx Only, Sterile](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2107-2023%22) May 31, 2023 FDA device enforcement ### [REF 218-1604-SP-10, Profile 0 4mm AutoDrive Screw Sterile Qty 10, Rx Only, Sterile](https://isitonrecall.com/recall/fda-device-z-2108-2023-ref-218-1604-sp-10-profile-0-4mm-autodrive-screw-sterile-qty-10-rx-only-sterile/) Screws for osteotomies have contain an undersize screwhead which has the potential to pass through the plate hole. Class II Reported ongoing Distribution: Worldwide - US Nationwide distribution in the states of AZ, CA, FL, GA, KS, KY, MD, MO, MT, NE, NY, TN, TX and the country of SG. [Official source for REF 218-1604-SP-10, Profile 0 4mm AutoDrive Screw Sterile Qty 10, Rx Only, Sterile](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2108-2023%22) Oct 28, 2021 FDA device enforcement ### [OsteoMed OsteoPower Power Console: -OsteoMed OsteoPower Power Console 2 REF 450-0021-00 -OsteoMed D-Power Control Console 2 REF 450-0021-01 -Power Control Console 2 REF ECOS-450...](https://isitonrecall.com/recall/fda-device-z-0335-2022-osteomed-osteopower-power-console-osteomed-osteopower-power-console-2-ref-450-0021-00-osteomed-d-pow/) Due to consoles not in compliance with the latest electrical safety standards IEC 60601 and as a result shocked a patient. Class II Reported ongoing Distribution: Worldwide distribution - U.S. Nationwide distribution in the states of AL, AR, AZ, CA, CO, CT, FL, GA, Guam, HI, ID, IL, IN, KS, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NJ, NM, ... [Official source for OsteoMed OsteoPower Power Console: -OsteoMed OsteoPower Power Console 2 REF 450-0021-00 -OsteoMed...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0335-2022%22) ## Reasons in these listed records - Screws for osteotomies have contain an undersize screwhead which has the potential to pass through the plate hole. - Due to consoles not in compliance with the latest electrical safety standards IEC 60601 and as a result shocked a patient. These examples come from this result page and are not a ranking of every recall reason. ## Checking Osteomed, LLC ### Is there a recall on osteomed, llc right now? This archive contains 3 records, including 3 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product. ### How do I check my package or product? Compare the product, firm and lot, date, model or serial identifiers with the notice. [Use the label-check guide](https://isitonrecall.com/guides/read-lot-codes/) if you need help locating an identifier. ### Does a matching name mean every item is included? A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall. ### What if the search finds no matching record? This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. [Check source coverage](https://isitonrecall.com/sources/) and the agency's current notices. ### Where can I find older records? Use [monthly archives](https://isitonrecall.com/archives/) or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page. ## Keep checking [Search Osteomed, LLC](https://isitonrecall.com/check/?q=Osteomed%2C%20LLC) [Browse related products](https://isitonrecall.com/products/) [Review source dates](https://isitonrecall.com/sources/)