IMPIX ALIF, REF numbers: a) B15111209, b) B15111212, c) B15111409, d) B15111412; intervertebral fusion devic
Summary
The FDA issued a Class II for IMPIX ALIF, REF numbers: a) B15111209, b) B15111212, c) B15111409, d) by Medicrea International. Reason: There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch..
Details
Source
Device Recall
External ID
Z-2453-2023
Action Date
2023-08-30
Status
Ongoing
Category
device
Product Description
IMPIX ALIF, REF numbers: a) B15111209, b) B15111212, c) B15111409, d) B15111412; intervertebral fusion device - lumbar
Lot/Code Info: a) B15111209, GTIN 03613720193395, Lot Numbers: 19C0772; b) B15111212, GTIN 03613720193401, Lot Numbers: 19C0775, 19G0070; c) B15111409, GTIN 03613720193425, Lot Numbers: 19E0353; d) B15111412, GTIN 03613720193432, Lot Numbers: 19C0788
Quantity Affected: 11 units
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.
Distribution
US nationwide
Type: Voluntary: Firm initiated
Recall Initiated: 2023-07-12
Company
Rillieux La Pape, N/A
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 152 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Medicrea International has 16 FDA actions in our database, including 14 recalls and 2 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Medicrea International) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Medicrea International have FDA actions?
Medicrea International has 16 FDA actions in our database, including 14 recalls and 2 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2453-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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