Recall Z-2456-2023— Medicrea International
Class II · Ongoing
Class II FDA medical device recall by Medicrea International, initiated 2023-07-12. It names one FDA 510(k) clearance: K100484. 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. Reason: There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch..
- Recalling firm
- Medicrea International
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-07-12
- Firm location
- Rillieux La Pape, N/A, France
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.