--- title: "Medicrea International Recalls: Agency-Reported Status and History (Oct 1, 2026) | Is It on Recall" description: "Search Medicrea International recall records, lots, firms and dates. Reported status can be incomplete; use the linked agency notice for current instructions." url: https://isitonrecall.com/brand/medicrea-international/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Home](https://isitonrecall.com/) / Brand archive # Medicrea International recall records **14** reported ongoing 14 records in this archive. Latest source date Oct 29, 2025. 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 Oct 29, 2025 FDA device enforcement ### [Medicrea, IB3D Universal Implant Inserter, Rx Only REF: A24000000](https://isitonrecall.com/recall/fda-device-z-1038-2026-medicrea-ib3d-universal-implant-inserter-rx-only-ref-a24000000/) Due to complaints, orthopedic rotation tool handle may untread from the shaft resulting in the inability to rotate implant. Class II Reported ongoing Distribution: US Nationwide distribution in the states of TN, CA, MN, NC, TX, FL, OH, RI, VA. [Official source for Medicrea, IB3D Universal Implant Inserter, Rx Only REF: A24000000](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1038-2026%22) Oct 29, 2025 FDA device enforcement ### [Medicrea, IB3D PL Instruments Set, Rx Only REF: SPS03174](https://isitonrecall.com/recall/fda-device-z-1039-2026-medicrea-ib3d-pl-instruments-set-rx-only-ref-sps03174/) Due to complaints, orthopedic rotation tool handle may untread from the shaft resulting in the inability to rotate implant. Class II Reported ongoing Distribution: US Nationwide distribution in the states of TN, CA, MN, NC, TX, FL, OH, RI, VA. [Official source for Medicrea, IB3D PL Instruments Set, Rx Only REF: SPS03174](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1039-2026%22) Dec 3, 2024 FDA device enforcement ### [UNiD" Adaptive Spine Intelligence UNiD Spine Analyzer Product Number SW3002 UDI-DI code 03613720286929 Two cloud-based software applications within UNiD Adaptive Spine Intellige...](https://isitonrecall.com/recall/fda-device-z-1118-2025-unid-adaptive-spine-intelligence-unid-spine-analyzer-product-number-sw3002-udi-di-code-0361372028692/) Due to software anomalies that may impact on rod planning specifically, certain optional surgical parameters may have had errors that resulted i incorrect calculations displayed on system. Impacted parameters includes the following: Roussouly Classification... Class II Reported ongoing Distribution: U.S.: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN,... [Official source for UNiD" Adaptive Spine Intelligence UNiD Spine Analyzer Product Number SW3002 UDI-DI code 036137202...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1118-2025%22) Jul 12, 2023 FDA device enforcement ### [IMPIX 3D, REF numbers: a) B242C09122810, b) B242C10062810, c) B242C10122810, d) B242C11062810, e) B242C11122810, f) B242C12062810, g) B242C12122810, h) B242C12123310, i) B242C13...](https://isitonrecall.com/recall/fda-device-z-2452-2023-impix-3d-ref-numbers-a-b242c09122810-b-b242c10062810-c-b242c10122810-d-b242c11062810-e-b242c11122810/) There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch. Class II Reported ongoing Distribution: US nationwide [Official source for IMPIX 3D, REF numbers: a) B242C09122810, b) B242C10062810, c) B242C10122810, d) B242C11062810, e)...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2452-2023%22) Jul 12, 2023 FDA device enforcement ### [IMPIX ALIF, REF numbers: a) B15111209, b) B15111212, c) B15111409, d) B15111412; intervertebral fusion device - lumbar](https://isitonrecall.com/recall/fda-device-z-2453-2023-impix-alif-ref-numbers-a-b15111209-b-b15111212-c-b15111409-d-b15111412-intervertebral-fusion-device/) There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch. Class II Reported ongoing Distribution: US nationwide [Official source for IMPIX ALIF, REF numbers: a) B15111209, b) B15111212, c) B15111409, d) B15111412; intervertebral f...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2453-2023%22) Jul 12, 2023 FDA device enforcement ### [IMPIX ALIF S/A, REF number B15241415; intervertebral fusion device - lumbar](https://isitonrecall.com/recall/fda-device-z-2454-2023-impix-alif-s-a-ref-number-b15241415-intervertebral-fusion-device-lumbar/) There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch. Class II Reported ongoing Distribution: US nationwide [Official source for IMPIX ALIF S/A, REF number B15241415; intervertebral fusion device - lumbar](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2454-2023%22) Jul 12, 2023 FDA device enforcement ### [IMPIX DLIF, REF numbers: a) B16123509, b) B16123511, c) B16124009, d) B16124013, e) B16124509, f) B16124511, g) B16124513, h) B16164009, i) B16164013, j) B16165009, k) B16165013...](https://isitonrecall.com/recall/fda-device-z-2455-2023-impix-dlif-ref-numbers-a-b16123509-b-b16123511-c-b16124009-d-b16124013-e-b16124509-f-b16124511-g-b16/) There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch. Class II Reported ongoing Distribution: US nationwide [Official source for IMPIX DLIF, REF numbers: a) B16123509, b) B16123511, c) B16124009, d) B16124013, e) B16124509, f)...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2455-2023%22) Jul 12, 2023 FDA device enforcement ### [IMPIX MANTA, REF numbers: a) A20150407, b) A20250407, c) A20350567, d) B20181743, e) B20181753, f) B20181763, g) B20181773, h) B20181943, i) B20181953, j) B20181963, k) B2018197...](https://isitonrecall.com/recall/fda-device-z-2456-2023-impix-manta-ref-numbers-a-a20150407-b-a20250407-c-a20350567-d-b20181743-e-b20181753-f-b20181763-g-b2/) There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch. Class II Reported ongoing Distribution: US nationwide [Official source for IMPIX MANTA, REF numbers: a) A20150407, b) A20250407, c) A20350567, d) B20181743, e) B20181753, f...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2456-2023%22) Jul 12, 2023 FDA device enforcement ### [IMPIX TLIF, REF numbers: a) B15130607S, b) B15130609S, c) B15130611S, d) B15130613S, e) B15130615S, f) B15900806, g) B15900906, h) B15901006, i) B15901106, j) B15901206, k) B159...](https://isitonrecall.com/recall/fda-device-z-2457-2023-impix-tlif-ref-numbers-a-b15130607s-b-b15130609s-c-b15130611s-d-b15130613s-e-b15130615s-f-b15900806/) There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch. Class II Reported ongoing Distribution: US nationwide [Official source for IMPIX TLIF, REF numbers: a) B15130607S, b) B15130609S, c) B15130611S, d) B15130613S, e) B15130615...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2457-2023%22) Jul 12, 2023 FDA device enforcement ### [PASS LP, REF numbers: a) B02315535Z, b) B02315540Z, c) B02315545Z, d) B02315550Z, e) B02316535Z, f) B02316540Z, g) B02316545Z, h) B02316550Z, i) B02317540Z, j) B02317545Z, k) B0...](https://isitonrecall.com/recall/fda-device-z-2458-2023-pass-lp-ref-numbers-a-b02315535z-b-b02315540z-c-b02315545z-d-b02315550z-e-b02316535z-f-b02316540z-g/) There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch. Class II Reported ongoing Distribution: US nationwide [Official source for PASS LP, REF numbers: a) B02315535Z, b) B02315540Z, c) B02315545Z, d) B02315550Z, e) B02316535Z, ...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2458-2023%22) Jul 12, 2023 FDA device enforcement ### [GRANVIA-C, REF numbers: a)¿¿¿¿¿ A13111427, b)¿¿¿¿ A13112567, c)¿¿¿¿¿ A13113456, d)¿¿¿¿ A13131516, e)¿¿¿¿ A13131789, f)¿¿¿¿¿¿ A13132012, g)¿¿¿¿¿ B13111014, h)¿¿¿¿ B13111015, i)¿¿...](https://isitonrecall.com/recall/fda-device-z-2459-2023-granvia-c-ref-numbers-a-a13111427-b-a13112567-c-a13113456-d-a13131516-e-a13131789-f-a13132012-g-b131/) There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch. Class II Reported ongoing Distribution: US nationwide [Official source for GRANVIA-C, REF numbers: a)¿¿¿¿¿ A13111427, b)¿¿¿¿ A13112567, c)¿¿¿¿¿ A13113456, d)¿¿¿¿ A13131516,...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2459-2023%22) Jul 12, 2023 FDA device enforcement ### [IMPIX C+, REF numbers: a) B20240104, b) B20240105, c) B20240106, d) B20240107, e) B20240205, f) B20240206, g) B20240207, h) B20240208; intervertebral fusion device - cervical](https://isitonrecall.com/recall/fda-device-z-2460-2023-impix-c-ref-numbers-a-b20240104-b-b20240105-c-b20240106-d-b20240107-e-b20240205-f-b20240206-g-b20240/) There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch. Class II Reported ongoing Distribution: US nationwide [Official source for IMPIX C+, REF numbers: a) B20240104, b) B20240105, c) B20240106, d) B20240107, e) B20240205, f) B...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2460-2023%22) Jul 12, 2023 FDA device enforcement ### [IMPIX S, REF numbers: a) B15328071S, b) B15328073S, c) B15328074S, d) B15334072S, e) B15334073S, f) B15334074S; intervertebral fusion device - cervical](https://isitonrecall.com/recall/fda-device-z-2461-2023-impix-s-ref-numbers-a-b15328071s-b-b15328073s-c-b15328074s-d-b15334072s-e-b15334073s-f-b15334074s-in/) There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch. Class II Reported ongoing Distribution: US nationwide [Official source for IMPIX S, REF numbers: a) B15328071S, b) B15328073S, c) B15328074S, d) B15334072S, e) B15334073S, ...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2461-2023%22) Jul 12, 2023 FDA device enforcement ### [IMPIX MANTA+, REF numbers: a) B20171743, b) B20171753, c) B20171763, d) B20171773, e) B20171943, f) B20171953, g) B20171963, h) B20171973, i) B20172253, j) B20172263, k) B201722...](https://isitonrecall.com/recall/fda-device-z-2462-2023-impix-manta-ref-numbers-a-b20171743-b-b20171753-c-b20171763-d-b20171773-e-b20171943-f-b20171953-g-b2/) There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch. Class II Reported ongoing Distribution: US nationwide [Official source for IMPIX MANTA+, REF numbers: a) B20171743, b) B20171753, c) B20171763, d) B20171773, e) B20171943, ...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2462-2023%22) ## Reasons in these listed records - Due to complaints, orthopedic rotation tool handle may untread from the shaft resulting in the inability to rotate implant. - Due to software anomalies that may impact on rod planning specifically, certain optional surgical parameters may have had errors that resulted i incorrect calculations displayed on system. Impacted parameters includes the following: Roussouly Classification, Real Lumbar Lordos... - There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch. These examples come from this result page and are not a ranking of every recall reason. ## Checking Medicrea International ### Is there a recall on medicrea international right now? This archive contains 14 records, including 14 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 Medicrea International](https://isitonrecall.com/check/?q=Medicrea%20International) [Browse related products](https://isitonrecall.com/products/) [Review source dates](https://isitonrecall.com/sources/)