Medicrea International
Complete recall history across all FDA and CPSC categories — 22 total recalls
Medicrea International appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.
Device Recalls (22)
FDA medical device enforcement actions by Medicrea International
| Date | Product | Reason | Class |
|---|---|---|---|
| Oct 29, 2025 | Medicrea, IB3D Universal Implant Inserter, Rx Only REF: A24000000 | Due to complaints, orthopedic rotation tool handle may untread from the shaf... | Class II |
| Oct 29, 2025 | Medicrea, IB3D PL Instruments Set, Rx Only REF: SPS03174 | Due to complaints, orthopedic rotation tool handle may untread from the shaf... | Class II |
| Dec 3, 2024 | UNiD" Adaptive Spine Intelligence UNiD Spine Analyzer Product Number SW300... | Due to software anomalies that may impact on rod planning specifically, certa... | Class II |
| Jul 12, 2023 | IMPIX ALIF S/A, REF number B15241415; intervertebral fusion device - lumbar | There is a potential for a product packaging non-conformity issue which prese... | Class II |
| Jul 12, 2023 | PASS LP, REF numbers: a) B02315535Z, b) B02315540Z, c) B02315545Z, d... | There is a potential for a product packaging non-conformity issue which prese... | Class II |
| Jul 12, 2023 | IMPIX TLIF, REF numbers: a) B15130607S, b) B15130609S, c) B15130611S, ... | There is a potential for a product packaging non-conformity issue which prese... | Class II |
| Jul 12, 2023 | IMPIX 3D, REF numbers: a) B242C09122810, b) B242C10062810, c) B242C10... | There is a potential for a product packaging non-conformity issue which prese... | Class II |
| Jul 12, 2023 | IMPIX DLIF, REF numbers: a) B16123509, b) B16123511, c) B16124009, ... | There is a potential for a product packaging non-conformity issue which prese... | Class II |
| Jul 12, 2023 | IMPIX MANTA+, REF numbers: a) B20171743, b) B20171753, c) B20171763, ... | There is a potential for a product packaging non-conformity issue which prese... | Class II |
| Jul 12, 2023 | GRANVIA-C, REF numbers: a)¿¿¿¿¿ A13111427, b)¿¿¿¿ A13112567, c)¿¿¿¿¿ A... | There is a potential for a product packaging non-conformity issue which prese... | Class II |
| Jul 12, 2023 | IMPIX ALIF, REF numbers: a) B15111209, b) B15111212, c) B15111409, ... | There is a potential for a product packaging non-conformity issue which prese... | Class II |
| Jul 12, 2023 | IMPIX MANTA, REF numbers: a) A20150407, b) A20250407, c) A20350567, ... | There is a potential for a product packaging non-conformity issue which prese... | Class II |
| Jul 12, 2023 | IMPIX C+, REF numbers: a) B20240104, b) B20240105, c) B20240106, d)... | There is a potential for a product packaging non-conformity issue which prese... | Class II |
| Jul 12, 2023 | IMPIX S, REF numbers: a) B15328071S, b) B15328073S, c) B15328074S, d... | There is a potential for a product packaging non-conformity issue which prese... | Class II |
| Oct 8, 2020 | MEDICREA LIGAPASS TENSION PULLEY HANDLE XS- intended to provide thoracic and... | Tightening the LIGAPASS Band with this instrument, the tensioner's pliers can... | Class II |
| Jan 28, 2020 | Iliac Screws, multiple sizes, Article Nos. B36020500 B36020570 B36020580 ... | An internal component was assembled in the incorrect orientation, which may l... | Class II |
| Jan 28, 2020 | Pedicle Screws, multiple sizes, Article Nos. B36004525 B36004530 B360045... | An internal component was assembled in the incorrect orientation, which may l... | Class II |
| Nov 11, 2019 | Medicrea International Universal Counter Torque for use with the Pass TULIP [... | Incompatible universal counter torque (A22020500) with the nut driver T30 (A... | Class II |
| Oct 2, 2019 | Medicrea TLIF-B Holder, short intended for Intervertebral body fusion device ... | Inner draw rod, which threads into the cage may potentially be separated from... | Class II |
| Sep 16, 2019 | Medicrea Pass LP Blunt K-wire 01.6mm x 500mm-Nitinol Product reference: A060... | Conical Cannulated Screws may not accept 1.6mm K-Wire, it cannot enter the mi... | Class II |
| Sep 16, 2019 | Medicrea Pass LP Trocar K-wire 01.6mm x 500mm-Nitinol Product reference : A0... | Conical Cannulated Screws may not accept 1.6mm K-Wire, it cannot enter the mi... | Class II |
| Jun 27, 2019 | Medicrea Pass LP, REF B02217545, Non Sterile, Material: Ti-6Al-4V ELI, VIS PE... | It has been determined that some Pedicle system screw identified as 45mm lon... | Class II |
Frequently Asked Questions
A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.
Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.
The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.
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