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
Reported: August 30, 2023 Initiated: July 12, 2023 #Z-2462-2023
Product Description
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
Reason for Recall
There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch.
Details
- Recalling Firm
- Medicrea International
- Units Affected
- N/A
- Distribution
- US nationwide
- Location
- Rillieux La Pape, N/A
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Medicrea International. Units affected: N/A.
Why was this product recalled? ▼
There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 30, 2023. Severity: Moderate. Recall number: Z-2462-2023.
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