Medicrea International recalls
Every recall we track for Medicrea International — 22 in all, from 2019–2025 — plus the complaints and injury reports the public filed about them.
Recalls per year, by danger level
Recalls from Medicrea International peaked in 2023 (11); 22 since 2017.
All FDA recall records for Medicrea International since 2017, counted by recall date (one bar per calendar year; 2026 is partial). Danger level is GovInfoNow’s plain-language rating; “not yet rated” records are still being written up.
| Year | Stop using now | Use caution | Lower risk | Not yet rated | Total |
|---|---|---|---|---|---|
| 2017 | 0 | 0 | 0 | 0 | 0 |
| 2018 | 0 | 0 | 0 | 0 | 0 |
| 2019 | 0 | 1 | 3 | 1 | 5 |
| 2020 | 0 | 2 | 1 | 0 | 3 |
| 2021 | 0 | 0 | 0 | 0 | 0 |
| 2022 | 0 | 0 | 0 | 0 | 0 |
| 2023 | 0 | 0 | 11 | 0 | 11 |
| 2024 | 0 | 0 | 1 | 0 | 1 |
| 2025 | 0 | 2 | 0 | 0 | 2 |
| 2026 (to date) | 0 | 0 | 0 | 0 | 0 |
What to do if you have a recalled Medicrea International product
- Match the model, catalog or lot number on your device to the recall.
- Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals.
- Report problems to FDA MedWatch.
All Medicrea International recalls
9 shown- Use cautionMedical device
Medicrea International recalls Medicrea, IB3D PL Instruments Set, Rx Only REF: SPS03174
Medicrea recalls IB3D PL Instruments Set (Rx Only) with serial numbers SPS03174 due to handle potentially untreading from shaft, causing inability to rotate implants.
MedicreaOct 29, 2025 - Lower riskMedical device
Medicrea International recalls UNiD" Adaptive Spine Intelligence UNiD Spine Analyzer Product Number SW3002 UDI-DI code 03613720286929 Two cloud-based
Medicrea recalls UNiD Spine Analyzer software (SW3002) due to potential errors in surgical planning calculations. Affected users should contact for remedy.
MedicreaDec 3, 2024 - Lower riskMedical device
Medicrea International recalls IMPIX S, REF numbers: a) B15328071S, b) B15328073S, c) B15328074S, d) B15334072S, e) B15334073S, f) B15334074S;
Medicrea recalls IMPIX S spinal fusion devices with specific reference numbers due to potential pinhole in packaging pouches. Affected units may have packaging defects that could lead to product contamination.
MedicreaJul 12, 2023 - Use cautionMedical device
Medicrea International recalls MEDICREA LIGAPASS TENSION PULLEY HANDLE XS- intended to provide thoracic and/or lumbar posterior stabilization for
Medicrea recalls LIGAPASS Tension Pulley Handle XS- for potential band breakage during surgery, risking infection and reoperation. Affected units have specific lot numbers and were sold from 2017-2019.
MedicreaOct 8, 2020 - Lower riskMedical device
Medicrea International recalls Pedicle Screws, multiple sizes, Article Nos. B36004525 B36004530 B36004535 B36004540 B36004545 B36004550 B36004555
Medicrea International recalls pedicle screws (article numbers B36004525-B36009560) due to incorrect internal component assembly that may cause tulip head disengagement during surgery.
Medicrea InternationalJan 28, 2020 - Lower riskMedical device
Medicrea International recalls Medicrea International Universal Counter Torque for use with the Pass TULIP [Spinal] System Ref : A22020500
Medicrea International recalls Universal Counter Torque (A22020500) due to incompatibility with Pass TULIP [Spinal] System nut drivers. Affected units may cause improper installation.
Medicrea InternationalNov 11, 2019 - Lower riskMedical device
Medicrea International recalls Medicrea TLIF-B Holder, short intended for Intervertebral body fusion device Catalog: Number A24200010
Medicrea recalls TLIF-B Holders (Catalog A24200010) due to potential separation of inner draw rod from proximal knob. Affected units sold with Lot Numbers l9B0570 or l9B0572.
MedicreaOct 2, 2019 - Lower riskMedical device
Medicrea International recalls Medicrea Pass LP Trocar K-wire 01.6mm x 500mm-Nitinol Product reference : A06010130
Medicrea recalls Pass LP Trocar K-wire 01.6mm x 500mm Nitinol product due to potential fitting issues. Affected units may not accept 1.6mm K-wire, risking improper use in medical procedures.
MedicreaSep 16, 2019 - Use cautionMedical device
Medicrea International recalls Medicrea Pass LP, REF B02217545, Non Sterile, Material: Ti-6Al-4V ELI, VIS PEDICULAIRE POLYAXIALE 7.5MM x 45MM,
Medicrea recalls Pass LP screws (7.5mm x 45mm) that may be too long, causing postoperative pain. Affected units have specific lot numbers and expiration dates.
MedicreaJun 27, 2019
Medicrea International recall questions
How many recalls has Medicrea International had?
22 recalls from Medicrea International are on record with U.S. safety agencies, from 2019–2025.
What is the most recent Medicrea International recall?
Medicrea International recalls Medicrea, IB3D PL Instruments Set, Rx Only REF: SPS03174, dated Oct 29, 2025. Every Medicrea International recall is listed on this page, newest first.
What should I do if I have a recalled Medicrea International product?
Match the model, catalog or lot number on your device to the recall. Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals. Report problems to FDA MedWatch.
How do I get alerts for new Medicrea International recalls?
Sign up for free email alerts on GovInfoNow — we check official CPSC, FDA, USDA and NHTSA data every day and email you only when a recall matches what you follow.