--- title: "OrthoPediatrics Corp Recalls: Agency-Reported Status and History (Oct 1, 2026) | Is It on Recall" description: "Search OrthoPediatrics Corp recall records, lots, firms and dates. Reported status can be incomplete; use the linked agency notice for current instructions." url: https://isitonrecall.com/brand/orthopediatrics-corp/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Home](https://isitonrecall.com/) / Brand archive # OrthoPediatrics Corp recall records **2** reported ongoing 2 records in this archive. Latest source date Sep 12, 2022. 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 Sep 12, 2022 FDA device enforcement ### [Orthex Large Bone Shoulder Bolt, model no. AS-17](https://isitonrecall.com/recall/fda-device-z-0277-2023-orthex-large-bone-shoulder-bolt-model-no-as-17/) Bolt breakage on the head or threaded portion, which may cause loss of strut continuity with frame. This may cause loss of deformity correction and/or disruption of bone regeneration. Class II Reported ongoing Distribution: Domestic distribution to Foreign distribution to [Official source for Orthex Large Bone Shoulder Bolt, model no. AS-17](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0277-2023%22) Jun 29, 2022 FDA device enforcement ### [Orthex External Fixation Wire Sharp Bayonet 1.8 x 400 mm Model: K400-18BN](https://isitonrecall.com/recall/fda-device-z-1678-2022-orthex-external-fixation-wire-sharp-bayonet-1-8-x-400-mm-model-k400-18bn/) Manufacturing variance near transition of tip is increasing the likelihood the wire tip may fracture. The fractured tip may be retained in the patient. Retrieval attempts may be made which could result in a delay of surgery and potentially damage soft tissu... Class II Reported ongoing Distribution: US Nationwide Distribution: AZ, AL, CA, FL, FL, MD, MO, NC, NY, TX Foreign: Australia [Official source for Orthex External Fixation Wire Sharp Bayonet 1.8 x 400 mm Model: K400-18BN](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1678-2022%22) ## Reasons in these listed records - Bolt breakage on the head or threaded portion, which may cause loss of strut continuity with frame. This may cause loss of deformity correction and/or disruption of bone regeneration. - Manufacturing variance near transition of tip is increasing the likelihood the wire tip may fracture. The fractured tip may be retained in the patient. Retrieval attempts may be made which could result in a delay of surgery and potentially damage soft tissue and increase heali... These examples come from this result page and are not a ranking of every recall reason. ## Checking OrthoPediatrics Corp ### Is there a recall on orthopediatrics corp right now? This archive contains 2 records, including 2 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 OrthoPediatrics Corp](https://isitonrecall.com/check/?q=OrthoPediatrics%20Corp) [Browse related products](https://isitonrecall.com/products/) [Review source dates](https://isitonrecall.com/sources/)