IMPIX C+, REF numbers: a) B20240104, b) B20240105, c) B20240106, d) B20240107, e) B20240205, f) B20240206, g) B20240207, h) B20240208; intervertebral fusion device - cervical
Class I - DangerousWhat Should You Do?
- Check if you have this product: a) B20240104, GTIN 03613720234241, Lot Numbers: 19A0773, 19B0524, 19C0511, 19E0477, 19K0180; b) B20240105, GTIN 03613720234258, Lot Numbers: 18K0653, 18L0497, 19A0636, 19A0654, 19B0189, 19C0512, 19C0664, 19I0849, 19L0701, 20G0851, 20H0262, 20I0570, 20I0877, 21D0764; c) B20240106, GTIN 03613720234265, Lot Numbers: 18C0676R, 18C0677, 18D0172, 19E0573, 19K0687, 20B0586, 20H0263, 20J0077, 21D0148, 21J0504, 22B0181; d) B20240107, GTIN 03613720234272, Lot Numbers: 18D0174, 18L0401, 18L0498, 19D0672, 19E0087, 19G1092, 19K0478, 20B0587, 20H0264, 21H0507, 22B0485; e) B20240205, GTIN 03613720234319, Lot Numbers: 22D0384, 22G0443; f) B20240206, GTIN 03613720234326, Lot Numbers: 20H0265, 22B0182; g) B20240207, GTIN 03613720234333, Lot Numbers: 18I0761, 18J0489, 19C0513, 20A0488, 20H0266; h) B20240208, GTIN 03613720234340, Lot Numbers: 18K0298, 19D0565, 19I0617, 20C0164, 20H0267, 22A0736
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Medicrea International
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
IMPIX C+, REF numbers: a) B20240104, b) B20240105, c) B20240106, d) B20240107, e) B20240205, f) B20240206, g) B20240207, h) B20240208; intervertebral fusion device - cervical
Product Codes/Lot Numbers:
a) B20240104, GTIN 03613720234241, Lot Numbers: 19A0773, 19B0524, 19C0511, 19E0477, 19K0180; b) B20240105, GTIN 03613720234258, Lot Numbers: 18K0653, 18L0497, 19A0636, 19A0654, 19B0189, 19C0512, 19C0664, 19I0849, 19L0701, 20G0851, 20H0262, 20I0570, 20I0877, 21D0764; c) B20240106, GTIN 03613720234265, Lot Numbers: 18C0676R, 18C0677, 18D0172, 19E0573, 19K0687, 20B0586, 20H0263, 20J0077, 21D0148, 21J0504, 22B0181; d) B20240107, GTIN 03613720234272, Lot Numbers: 18D0174, 18L0401, 18L0498, 19D0672, 19E0087, 19G1092, 19K0478, 20B0587, 20H0264, 21H0507, 22B0485; e) B20240205, GTIN 03613720234319, Lot Numbers: 22D0384, 22G0443; f) B20240206, GTIN 03613720234326, Lot Numbers: 20H0265, 22B0182; g) B20240207, GTIN 03613720234333, Lot Numbers: 18I0761, 18J0489, 19C0513, 20A0488, 20H0266; h) B20240208, GTIN 03613720234340, Lot Numbers: 18K0298, 19D0565, 19I0617, 20C0164, 20H0267, 22A0736
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2460-2023
Related Recalls
Due to software anomalies that may impact on rod planning specifically, certain optional surgical parameters may have had errors that resulted i incorrect calculations displayed on system. Impacted parameters includes the following: Roussouly Classification, Real Lumbar Lordosis and Real Thoracic Kyphosis, Barrey Ratio, and Lenke Classification.
IMPIX S, REF numbers: a) B15328071S, b) B15328073S, c) B15328074S, d) B15334072S, e) B15334073S, f) B15334074S; intervertebral fusion device - cervical
Medicrea International
There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch.
There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch.