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Medicrea International

20 recalls •

🏥 Medical Devices

• Categories: Infusion Pumps, Other Medical Devices

UNiD" 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 Analyzer cloud based software is a healthcare application intended for assisting healthcare professionals in viewing and measuring images as well as planning spine surgeries.

Class I - Dangerous

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.

Dec 3, 2024 Infusion Pumps Nationwide View Details →

IMPIX S, REF numbers: a) B15328071S, b) B15328073S, c) B15328074S, d) B15334072S, e) B15334073S, f) B15334074S; intervertebral fusion device - cervical

Class I - Dangerous

There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch.

Jul 12, 2023 Other Medical Devices Nationwide View Details →

IMPIX C+, REF numbers: a) B20240104, b) B20240105, c) B20240106, d) B20240107, e) B20240205, f) B20240206, g) B20240207, h) B20240208; intervertebral fusion device - cervical

Class I - Dangerous

There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch.

Jul 12, 2023 Other Medical Devices Nationwide View Details →

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) B20181973, l) B20182253, m) B20182263; intervertebral fusion device - lumbar

Class I - Dangerous

There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch.

Jul 12, 2023 Other Medical Devices Nationwide View Details →

IMPIX ALIF, REF numbers: a) B15111209, b) B15111212, c) B15111409, d) B15111412; intervertebral fusion device - lumbar

Class I - Dangerous

There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch.

Jul 12, 2023 Other Medical Devices Nationwide View Details →

GRANVIA-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

Class I - Dangerous

There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch.

Jul 12, 2023 Other Medical Devices Nationwide View Details →

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) B20172273; intervertebral fusion device - cervical

Class I - Dangerous

There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch.

Jul 12, 2023 Other Medical Devices Nationwide View Details →

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; intervertebral fusion device - lumbar

Class I - Dangerous

There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch.

Jul 12, 2023 Other Medical Devices Nationwide View Details →

IMPIX 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) B247C10063210, y) B247C11062410, z) B247C11062810, aa) B247C11063210, bb) B247C12062410, cc) B247C12062810, dd) B247C12063210, ee) B247C13062410, ff) B247C13062810, gg) B247C13063210, hh) B247C14062410, ii) B247C14062810, jj) B247C14063210, kk) B247C15062810, ll) B247C15063210; intervertebral fusion device - lumbar

Class I - Dangerous

There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch.

Jul 12, 2023 Other Medical Devices Nationwide View Details →

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) B15901306; intervertebral fusion device - lumbar

Class I - Dangerous

There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch.

Jul 12, 2023 Other Medical Devices Nationwide View Details →

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) B02317550Z; intervertebral fusion device - cervical

Class I - Dangerous

There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch.

Jul 12, 2023 Other Medical Devices Nationwide View Details →

IMPIX ALIF S/A, REF number B15241415; intervertebral fusion device - lumbar

Class I - Dangerous

There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch.

Jul 12, 2023 Other Medical Devices Nationwide View Details →

MEDICREA LIGAPASS TENSION PULLEY HANDLE XS- intended to provide thoracic and/or lumbar posterior stabilization for degenerative pathologies Ref : A08200200

Class I - Dangerous

Tightening the LIGAPASS Band with this instrument, the tensioner's pliers can crush the band causing the band to break during surgery and lead to a risk of infection and re-intervention ,

Oct 8, 2020 Infusion Pumps View Details →

Pedicle Screws, multiple sizes, Article Nos. B36004525 B36004530 B36004535 B36004540 B36004545 B36004550 B36004555 B36005530 B36005535 B36005540 B36005545 B36005550 B36005555 B36005560 B36006530 B36006535 B36006540 B36006545 B36006550 B36006555 B36006560 B36007535 B36007540 B36007545 B36007550 B36007555 B36007560 B36008535 B36008540 B36008545 B36008550 B36008555 B36008560 B36009535 B36009540 B36009545 B36009550 B36009555 B36009560 Screws manufactured in titanium alloy Ti-6Al-4V LI conforming to ISO5832-3 and ASTM. F136 specifications. These screws are part of an internal fixation system composed of hooks, rods, plates, cross links, connection and locking devices.

Class I - Dangerous

An internal component was assembled in the incorrect orientation, which may lead to the tulip head disengaging from the crew shank during or after screw insertion, or during the reduction step.

Jan 28, 2020 Other Medical Devices Nationwide View Details →

Iliac Screws, multiple sizes, Article Nos. B36020500 B36020570 B36020580 B36020590 B36027500 B36027570 B36027580 B36027590 B36028500 B36028570 B36028580 B36028590 B36029500 B36029570 B36029580 B36029590 Screws manufactured in titanium alloy Ti-6Al-4V LI conforming to ISO5832-3 and ASTM. F136 specifications. These screws are part of an internal fixation system composed of hooks, rods, plates, cross links, connection and locking devices.

Class I - Dangerous

An internal component was assembled in the incorrect orientation, which may lead to the tulip head disengaging from the crew shank during or after screw insertion, or during the reduction step.

Jan 28, 2020 Other Medical Devices Nationwide View Details →

Medicrea International Universal Counter Torque for use with the Pass TULIP [Spinal] System Ref : A22020500

Class I - Dangerous

Incompatible universal counter torque (A22020500) with the nut driver T30 (A22020220)

Nov 11, 2019 Infusion Pumps View Details →

Medicrea TLIF-B Holder, short intended for Intervertebral body fusion device Catalog: Number A24200010

Class I - Dangerous

Inner draw rod, which threads into the cage may potentially be separated from the proximal knob of the inserter

Oct 2, 2019 Other Medical Devices View Details →

Medicrea Pass LP Trocar K-wire 01.6mm x 500mm-Nitinol Product reference : A06010130

Class I - Dangerous

Conical Cannulated Screws may not accept 1.6mm K-Wire, it cannot enter the minimum tolerance axis threaded

Sep 16, 2019 Other Medical Devices Nationwide View Details →

Medicrea Pass LP Blunt K-wire 01.6mm x 500mm-Nitinol Product reference: A06010140

Class I - Dangerous

Conical Cannulated Screws may not accept 1.6mm K-Wire, it cannot enter the minimum tolerance axis threaded

Sep 16, 2019 Other Medical Devices Nationwide View Details →

Medicrea Pass LP, REF B02217545, Non Sterile, Material: Ti-6Al-4V ELI, VIS PEDICULAIRE POLYAXIALE 7.5MM x 45MM, POLYAXIAL PEDICLE SCREW 7.5MM x 45 MM, POLYAXIAL PEDIKELSCHRAUBE 7.5MM X 45MM, TORNILLO PEDICULAR POLIAXIAL 7.5MM x 45MM VITE POLIASSIALE PEDUNCOLARE 7.5MM x 45MM, PARAFUSO PEDICULAR POLIAXIAL 7.5MM x 45MM, POLYAXIALE PEDICULAIRE SCHROEF 7.5MM x 45MM, POLYAXIALE PEDICULAIRE SCHROEF 7.5MM x 45MM, WIELOOSIOWA SRUBA TRANSPEDIKULARNA 7.5MM x 45MM, (01)03613720177906(10)19A0630(17)290103, RX only

Class I - Dangerous

It has been determined that some Pedicle system screw identified as 45mm long have an actual length of 50mm. Pedicle screws with a diameter of 7.5 mm or more are reserved for the sacrum area. As a result, a screw that is too long could come into contact with the nerves and cause postoperative pain.

Jun 27, 2019 Other Medical Devices View Details →