Recall Z-2460-2023— Medicrea International
Class II · Ongoing
Class II FDA medical device recall by Medicrea International, initiated 2023-07-12. FDA's recall record names no specific 510(k) clearance for this event. Product: IMPIX C+, REF numbers: a) B20240104, b) B20240105, c) B20240106, d) B20240107, e) B20240205, f) B20240206, g) B20240207, h) B20240208; intervertebral fusion device - cervical. 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
Product description
IMPIX C+, REF numbers: a) B20240104, b) B20240105, c) B20240106, d) B20240107, e) B20240205, f) B20240206, g) B20240207, h) B20240208; 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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.