Reported Aug 30, 2023 · Ongoing
PASS LP, REF numbers: a) B02315535Z, b) B02315540Z, c) B02315545Z, d) B02315550Z, e) B02316535Z, f) B02316540Z, 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?
11 of 11 products
| # | Product as published |
|---|---|
| 1 | B02315535Z |
| 2 | B02315540Z |
| 3 | B02315545Z |
| 4 | B02315550Z |
| 5 | B02316535Z |
| 6 | B02316540Z |
| 7 | B02316545Z |
| 8 | B02316550Z |
| 9 | B02317540Z |
| 10 | B02317545Z |
| 11 | B02317550Z; intervertebral fusion device - cervical |
- Lot codes and dates
11 of 11 products
Products covered by this recall Model / number Product as published 03613720185086B02315535Z, , Lot Numbers: 21J0184 03613720185116B02315540Z, , Lot Numbers: 18E0322, 18F1011, 18G0704, 18I0780, 18K0862, 19B0091, 19B0731, 19D0267, 19F0460, 19J0742, 20A0966, 20F0008, 20I0200, 20I0833, 22I0616 03613720185147B02315545Z, , Lot Numbers: 18H0617, 18I0682, 18J0215, 18K0863, 19K0545, 20H0147 03613720185178B02315550Z, , Lot Numbers: 19E0306, 20F0009 03613720185321B02316535Z, , Lot Numbers: 21J0185, 21J0899 03613720185352B02316540Z, , Lot Numbers: 18E0478, 18H0672, 18K0278, 18K0864, 19A0645, 19B0318, 19B0777, 19C0417, 19C0739, 19E0082, 19I0573, 20A0596, 20B0687, 20H0148, 20J0414, 21A0107, 22A0297, 22I0339 03613720185383B02316545Z, , Lot Numbers: 18D1035, 18E0508, 18F0534, 18G0170, 18G0591, 18H0588, 18J0054, 18K0279, 18K0865, 19A0066, 19B0093, 19B0912, 19C0138, 19D0177, 19E0084, 19G0188, 19J0227, 19J0228, 19K0764, 19L0360, 19L0580, 20B0688, 20H0151, 20J0415, 20L0238, 21A0109, 21A0642, 21D0174, 21F0505, 21L0394, 22A0047, 22L0091 03613720185413B02316550Z, , Lot Numbers: 21A0506, 21C0501 03613720185598B02317540Z, , Lot Numbers: 21A0110, 21A0508, 21A0524, 22B0782 03613720185628B02317545Z, , Lot Numbers: 20E0097, 21A0076, 21B0498 03613720185659B02317550Z, , Lot Numbers: 20C0294, 20H0508, 20J0283, 22B0366 - Amount recalled
- 963 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.
Want the full recall guide?
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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