Recall Z-2461-2023— 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 S, REF numbers: a) B15328071S, b) B15328073S, c) B15328074S, d) B15334072S, e) B15334073S, f) B15334074S; 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 S, REF numbers: a) B15328071S, b) B15328073S, c) B15328074S, d) B15334072S, e) B15334073S, f) B15334074S; 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.