Intervertebral fusion device recalled for packaging non-conformity issue
Medicrea International is recalling 4,489 IMPIX MANTA intervertebral fusion devices due to potential pinholes in product packaging that could compromise device sterility.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall of a sterile medical implant device where packaging integrity is essential. A pinhole in device packaging represents a risk-of-harm scenario due to potential contamination exposure, though no illnesses or injuries have been reported.
Plain-English summary
Medicrea International is recalling 4,489 units of IMPIX MANTA intervertebral fusion devices for lumbar spine use. The recall was initiated due to a potential packaging non-conformity issue that presents as a pinhole in either the inner or outer pouch of the product packaging.
The affected devices were distributed throughout the United States. A pinhole in the packaging could potentially compromise the sterility of the device, which is critical for safe use of an implant.
No illnesses or injuries have been reported in connection with this recall. Patients who have received an IMPIX MANTA device should consult with their healthcare provider if they have concerns.
The recalled product
- Product
- 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
- Manufacturer
- Medicrea International
- Affected units
- 4,489
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- a) A20150407
- GTIN 03613720236016
- Lot Numbers: 18F0803
- 18J0713
- 18J0714
- 19A0225
- 19A0786
- 19A0787
- 19D0381
- 19D0382
- 19J0594
- 20A0280
- 20H0285
- 20I0475
- 20K0424
- 21D0442
- 21I0596
- 22E0637
- b) A20250407
- GTIN 03613720236078
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 11 recalled by Medicrea International under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 11 products in this recall →Related recalls
Same manufacturer · Medicrea International
See all →- ModerateUniversal implant inserters recalled because the rotation tool handle can untread
FDA (Devices) · 2026-01-21
- ModerateSpinal instrument sets recalled because the rotation tool handle can untread
FDA (Devices) · 2026-01-21
- HighSpine Surgery Planning Software Calculation Errors in Rod Planning Parameters
FDA (Devices) · 2025-02-12
- HighMedicrea Cervical Fusion Implants Recalled for Packaging Defect
FDA (Devices) · 2023-08-30
- HighIntervertebral Fusion Device Recalled for Potential Packaging Defect
FDA (Devices) · 2023-08-30
Same hazard · packaging defect
See all →- HighMD Wipe Outz Numbing Tattoo Wipes Recalled for Child Poisoning Risk
CPSC · 2026-08-27
- SevereDermalon Sutures Recalled for Potential Sterile Barrier Packaging Defects
FDA (Devices) · 2026-08-19
- HighV-Loc 90 Absorbable Wound Closure Devices Recalled for Packaging Defects
FDA (Devices) · 2026-08-19
- HighV-Loc 180 Absorbable Wound Closure Device Recalled for Packaging Defects
FDA (Devices) · 2026-08-19
- HighBiopsy Forceps Recall: Sterile Packaging Breach Risk
FDA (Devices) · 2026-08-12