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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. Source coverage and dates.

Records and reported status

Oct 29, 2025FDA device enforcement

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 IIReported ongoing

Distribution: US Nationwide distribution in the states of TN, CA, MN, NC, TX, FL, OH, RI, VA.

Official source

Oct 29, 2025FDA device enforcement

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 IIReported ongoing

Distribution: US Nationwide distribution in the states of TN, CA, MN, NC, TX, FL, OH, RI, VA.

Official source

Dec 3, 2024FDA 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...

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 IIReported 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

Jul 12, 2023FDA device enforcement

IMPIX 3D, REF numbers: a) B242C09122810, b) B242C10062810, c) B242C10122810, d) B242C11062810, e) B242C11122810, f) B242C12062810, g) B242C12122810, h) B242C12123310, i) B242C13...

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

Class IIReported ongoing

Distribution: US nationwide

Official source

Jul 12, 2023FDA device enforcement

IMPIX 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.

Class IIReported ongoing

Distribution: US nationwide

Official source

Jul 12, 2023FDA device enforcement

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 IIReported ongoing

Distribution: US nationwide

Official source

Jul 12, 2023FDA 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...

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

Class IIReported ongoing

Distribution: US nationwide

Official source

Jul 12, 2023FDA 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...

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

Class IIReported ongoing

Distribution: US nationwide

Official source

Jul 12, 2023FDA 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...

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

Class IIReported ongoing

Distribution: US nationwide

Official source

Jul 12, 2023FDA 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...

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

Class IIReported ongoing

Distribution: US nationwide

Official source

Jul 12, 2023FDA device enforcement

GRANVIA-C, REF numbers: a)¿¿¿¿¿ A13111427, b)¿¿¿¿ A13112567, c)¿¿¿¿¿ A13113456, d)¿¿¿¿ A13131516, e)¿¿¿¿ A13131789, f)¿¿¿¿¿¿ A13132012, g)¿¿¿¿¿ B13111014, h)¿¿¿¿ B13111015, i)¿¿...

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

Class IIReported ongoing

Distribution: US nationwide

Official source

Jul 12, 2023FDA 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

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

Class IIReported ongoing

Distribution: US nationwide

Official source

Jul 12, 2023FDA device enforcement

IMPIX 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.

Class IIReported ongoing

Distribution: US nationwide

Official source

Jul 12, 2023FDA 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...

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

Class IIReported ongoing

Distribution: US nationwide

Official source

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 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 and the agency's current notices.

Where can I find older records?

Use monthly 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.

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