Reported Aug 30, 2023 · Ongoing
IMPIX DLIF, REF numbers: a) B16123509, b) B16123511, c) B16124009, d) B16124013, e) B16124509, f) B16124511, g)…
Medicrea International
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Medicrea International · Vancia · Rillieux La Pape, N/A · N/A
Is this the product you have?
- IMPIX DLIF
- REF numbers
a) B16123509b) B16123511c) B16124009d) B16124013e) B16124509f) B16124511g) B16124513h) B16164009i) B16164013j) B16165009k) B16165013intervertebral fusion device - lumbar
- Lot codes and dates
11 of 11 products
Products covered by this recall Model / number Product as published 03613720196341B16123509, , Lot Numbers: 20B0490 03613720196358B16123511, , Lot Numbers: 19G0068 03613720196396B16124009, , Lot Numbers: 19K0269 03613720196419B16124013, , Lot Numbers: 19F0715 03613720196440B16124509, , Lot Numbers: 19F0713 03613720196457B16124511, , Lot Numbers: 19F0716 03613720196464B16124513, , Lot Numbers: 19K0270 03613720196495B16164009, , Lot Numbers: 18F1034 03613720196518B16164013, , Lot Numbers: 18G0178 03613720196594B16165009, , Lot Numbers: 18C0626 03613720196617B16165013, , Lot Numbers: 18C0629 - Amount recalled
- 24 units
This recall covers 11 products
The agency filed one notice per product. You are reading one of them; the other 10 are below.
Where it was sold
- Nationwide
Why it was recalled
There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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