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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
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