Medicrea IMPIX MANTA+ Cervical Fusion Devices Recalled for Packaging Defect
Medicrea International is recalling IMPIX MANTA+ cervical intervertebral fusion devices due to potential packaging non-conformity with pinholes in inner or outer pouches. No illnesses or injuries reported.
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: Although no illnesses or injuries have been reported and the packaging hazard is theoretical, this is a Class II recall involving a cervical medical device. Packaging defects on medical devices present a risk-of-harm situation, meeting the criteria for Score 3 per the rubric.
Plain-English summary
Medicrea International is recalling IMPIX MANTA+ cervical intervertebral fusion devices distributed nationwide in the United States. The recall affects multiple reference numbers ranging from B20171743 through B20172273.
The devices are being recalled due to a potential packaging non-conformity—specifically, pinholes that may be present in either the inner or outer pouch. No illnesses or injuries have been reported in connection with this recall.
Healthcare providers and facilities with these devices should verify the lot numbers against the recall notice. Patients who have received these devices should consult their healthcare provider if they have concerns about this packaging issue.
The recalled product
- Product
- 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) B20172273; intervertebral fusion device - cervical
- Manufacturer
- Medicrea International
- Hazard
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) B20171743
- GTIN 03613720232636
- Lot Numbers: 18E0275
- 18E0404
- 18E0676
- 18E0833
- 18I0867
- 18K0143
- 18L0219
- 19A0463
- 19A0669
- 19B0870
- 19D0484
- 19G0192
- 19G0422
- 19J0468
- 19L0381
- 20F0631
- 20G0849
- 20H0596
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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