IMPIX DLIF, REF numbers: a) B16123509, b) B16123511, c) B16124009, d) B16124013, e) B16124509, f) B1612451
Summary
The FDA issued a Class II for IMPIX DLIF, REF numbers: a) B16123509, b) B16123511, c) B16124009, 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-2455-2023
Action Date
2023-08-30
Status
Ongoing
Category
device
Product Description
IMPIX DLIF, REF numbers: a) B16123509, b) B16123511, c) B16124009, d) B16124013, e) B16124509, f) B16124511, g) B16124513, h) B16164009, i) B16164013, j) B16165009, k) B16165013; intervertebral fusion device - lumbar
Lot/Code Info: a) B16123509, GTIN 03613720196341, Lot Numbers: 20B0490; b) B16123511, GTIN 03613720196358, Lot Numbers: 19G0068; c) B16124009, GTIN 03613720196396, Lot Numbers: 19K0269; d) B16124013, GTIN 03613720196419, Lot Numbers: 19F0715; e) B16124509, GTIN 03613720196440, Lot Numbers: 19F0713; f) B16124511, GTIN 03613720196457, Lot Numbers: 19F0716; g) B16124513, GTIN 03613720196464, Lot Numbers: 19K0270; h) B16164009, GTIN 03613720196495, Lot Numbers: 18F1034; i) B16164013, GTIN 03613720196518, Lot Numbers: 18G0178; j) B16165009, GTIN 03613720196594, Lot Numbers: 18C0626; k) B16165013, GTIN 03613720196617, Lot Numbers: 18C0629;
Quantity Affected: 24 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-2455-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
Want to know the moment something like this happens?
Get alerts for deviceRelated Actions
MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Straight Extensions, IC Tray REF: 888810200
Covidien LP · 2023-08-23
Sterile Procedural Trays, labeled as the following: a. BREAST AUGMENTATION b. BREAST REDUCTION CDS c. CUH ABDOMINO
MEDLINE INDUSTRIES, LP - Northfield · 2023-02-15
VTC Regular Kit Nephrostomy Catheter System Kit, Material Number REF M001245300; to provide external drainage of the uri
Boston Scientific Corporation · 2024-09-25
EnChroma Safety Glasses with Rx Indoor Universal Lenses: Martinez Cx1 Indoor Rx, SKU: Cx.PC.IN.MTZ.BK.Rx; Summit Indoo
Enchroma Inc · 2024-11-27
Otological Ventilation Tube - T-Tube 9mm - Silicone; Product Code: NZ3309;
Adept Medical Ltd · 2025-01-29