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
Reported: August 30, 2023 Initiated: July 12, 2023 #Z-2456-2023
Product Description
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
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
- 4489 units
- Distribution
- US nationwide
- Location
- Rillieux La Pape, N/A
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Medicrea International. Units affected: 4489 units.
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-2456-2023.
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