PASS LP, REF numbers: a) B02315535Z, b) B02315540Z, c) B02315545Z, d) B02315550Z, e) B02316535Z, f) B02316540Z, g) B02316545Z, h) B02316550Z, i) B02317540Z, j) B02317545Z, k) B02317550Z; intervertebral fusion device - cervical
Class I - DangerousWhat Should You Do?
- Check if you have this product: a) B02315535Z, GTIN 03613720185086, Lot Numbers: 21J0184; b) B02315540Z, GTIN 03613720185116, Lot Numbers: 18E0322, 18F1011, 18G0704, 18I0780, 18K0862, 19B0091, 19B0731, 19D0267, 19F0460, 19J0742, 20A0966, 20F0008, 20I0200, 20I0833, 22I0616; c) B02315545Z, GTIN 03613720185147, Lot Numbers: 18H0617, 18I0682, 18J0215, 18K0863, 19K0545, 20H0147; d) B02315550Z, GTIN 03613720185178, Lot Numbers: 19E0306, 20F0009; e) B02316535Z, GTIN 03613720185321, Lot Numbers: 21J0185, 21J0899; f) B02316540Z, GTIN 03613720185352, Lot Numbers: 18E0478, 18H0672, 18K0278, 18K0864, 19A0645, 19B0318, 19B0777, 19C0417, 19C0739, 19E0082, 19I0573, 20A0596, 20B0687, 20H0148, 20J0414, 21A0107, 22A0297, 22I0339; g) B02316545Z, GTIN 03613720185383, 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; h) B02316550Z, GTIN 03613720185413, Lot Numbers: 21A0506, 21C0501; i) B02317540Z, GTIN 03613720185598, Lot Numbers: 21A0110, 21A0508, 21A0524, 22B0782; j) B02317545Z, GTIN 03613720185628, Lot Numbers: 20E0097, 21A0076, 21B0498; k) B02317550Z, GTIN 03613720185659, Lot Numbers: 20C0294, 20H0508, 20J0283, 22B0366
- 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:
PASS LP, REF numbers: a) B02315535Z, b) B02315540Z, c) B02315545Z, d) B02315550Z, e) B02316535Z, f) B02316540Z, g) B02316545Z, h) B02316550Z, i) B02317540Z, j) B02317545Z, k) B02317550Z; intervertebral fusion device - cervical
Product Codes/Lot Numbers:
a) B02315535Z, GTIN 03613720185086, Lot Numbers: 21J0184; b) B02315540Z, GTIN 03613720185116, Lot Numbers: 18E0322, 18F1011, 18G0704, 18I0780, 18K0862, 19B0091, 19B0731, 19D0267, 19F0460, 19J0742, 20A0966, 20F0008, 20I0200, 20I0833, 22I0616; c) B02315545Z, GTIN 03613720185147, Lot Numbers: 18H0617, 18I0682, 18J0215, 18K0863, 19K0545, 20H0147; d) B02315550Z, GTIN 03613720185178, Lot Numbers: 19E0306, 20F0009; e) B02316535Z, GTIN 03613720185321, Lot Numbers: 21J0185, 21J0899; f) B02316540Z, GTIN 03613720185352, Lot Numbers: 18E0478, 18H0672, 18K0278, 18K0864, 19A0645, 19B0318, 19B0777, 19C0417, 19C0739, 19E0082, 19I0573, 20A0596, 20B0687, 20H0148, 20J0414, 21A0107, 22A0297, 22I0339; g) B02316545Z, GTIN 03613720185383, 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; h) B02316550Z, GTIN 03613720185413, Lot Numbers: 21A0506, 21C0501; i) B02317540Z, GTIN 03613720185598, Lot Numbers: 21A0110, 21A0508, 21A0524, 22B0782; j) B02317545Z, GTIN 03613720185628, Lot Numbers: 20E0097, 21A0076, 21B0498; k) B02317550Z, GTIN 03613720185659, Lot Numbers: 20C0294, 20H0508, 20J0283, 22B0366
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2458-2023
Related Recalls
Medicrea, IB3D PL Instruments Set, Rx Only REF: SPS03174
Medicrea International
Due to complaints, orthopedic rotation tool handle may untread from the shaft resulting in the inability to rotate implant.
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.