Medicrea International
12 federal recalls on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for Medicrea International and translate it into plain English — free weekly digest, optional same-day alerts.
- 2025-02-12FDA-DeviceClass IIUNiD" Adaptive Spine Intelligence UNiD Spine Analyzer Product Number SW3002 UDI-DI code 03613720286929 Two cloud-based software applications within UNiD Adaptive Spine Intelligence (ASI): the UNiD HUB and the UNiD Spine Analyzer. The UNiD HUB cloud-based software is a healthcare application to receive, transfer, display, store data needed for planning a spine surgery or for post-operative follow-up (patient information, X-ray image and recommendations for planning). The UNiD Spine Anal
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 Lordosis and Real Thoracic Kyphosis, Barrey Ratio, and Lenke Classification.
- 2023-08-30FDA-DeviceClass IIIMPIX MANTA+, REF numbers: a) B20171743, b) B20171753, c) B20171763, d) B20171773, e) B20171943, f) B20171953, g) B20171963, h) B20171973, i) B20172253, j) B20172263, k) B20172273; intervertebral fusion device - cervical
There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch.
- 2023-08-30FDA-DeviceClass IIIMPIX S, REF numbers: a) B15328071S, b) B15328073S, c) B15328074S, d) B15334072S, e) B15334073S, f) B15334074S; intervertebral fusion device - cervical
There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch.
- 2023-08-30FDA-DeviceClass IIIMPIX C+, REF numbers: a) B20240104, b) B20240105, c) B20240106, d) B20240107, e) B20240205, f) B20240206, g) B20240207, h) B20240208; intervertebral fusion device - cervical
There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch.
- 2023-08-30FDA-DeviceClass IIGRANVIA-C, REF numbers: a)¿¿¿¿¿ A13111427, b)¿¿¿¿ A13112567, c)¿¿¿¿¿ A13113456, d)¿¿¿¿ A13131516, e)¿¿¿¿ A13131789, f)¿¿¿¿¿¿ A13132012, g)¿¿¿¿¿ B13111014, h)¿¿¿¿ B13111015, i)¿¿¿¿¿¿ B13111016, j)¿¿¿¿¿¿ B13111017, k)¿¿¿¿¿ B13111025, l)¿¿¿¿¿¿ B13111026, m)¿¿¿ B13111027, n)¿¿¿¿ B13111034, o)¿¿¿¿ B13111035, p)¿¿¿¿ B13111036; intervertebral fusion device - cervical
There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch.
- 2023-08-30FDA-DeviceClass IIPASS LP, REF numbers: a) B02315535Z, b) B02315540Z, c) B02315545Z, d) B02315550Z, e) B02316535Z, f) B02316540Z, g) B02316545Z, h) B02316550Z, i) B02317540Z, j) B02317545Z, k) B02317550Z; intervertebral fusion device - cervical
There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch.
- 2023-08-30FDA-DeviceClass IIIMPIX TLIF, REF numbers: a) B15130607S, b) B15130609S, c) B15130611S, d) B15130613S, e) B15130615S, f) B15900806, g) B15900906, h) B15901006, i) B15901106, j) B15901206, k) B15901306; 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.
- 2023-08-30FDA-DeviceClass IIIMPIX MANTA, REF numbers: a) A20150407, b) A20250407, c) A20350567, d) B20181743, e) B20181753, f) B20181763, g) B20181773, h) B20181943, i) B20181953, j) B20181963, k) B20181973, l) B20182253, m) B20182263; 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.
- 2023-08-30FDA-DeviceClass IIIMPIX 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; 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.
- 2023-08-30FDA-DeviceClass IIIMPIX 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.
- 2023-08-30FDA-DeviceClass IIIMPIX ALIF, REF numbers: a) B15111209, b) B15111212, c) B15111409, d) B15111412; 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.
- 2023-08-30FDA-DeviceClass IIIMPIX 3D, REF numbers: a) B242C09122810, b) B242C10062810, c) B242C10122810, d) B242C11062810, e) B242C11122810, f) B242C12062810, g) B242C12122810, h) B242C12123310, i) B242C13062810, j) B242C13122810, k) B242C14122810, l) B242C15122810, m) B247C07062410, n) B247C07062810, o) B247C07063210, p) B247C08062410, q) B247C08062810, r) B247C08063210, s) B247C09062410, t) B247C09062810, u) B247C09063210, v) B247C10062410, w) B247C10062810, x) B247C10063
There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch.
Get notified about new Medicrea International recalls
Free weekly digest. We email when a new federal recall affects Medicrea International or anything else in your household.
Get the Sunday Brief