Medicrea Cervical Fusion Implants Recalled for Packaging Defect
Medicrea International is recalling 963 PASS LP cervical fusion implants due to potential pinholes in the device packaging. The recall affects units distributed nationwide.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical device recall for a sterile surgical product where packaging integrity is critical to prevent contamination. The pinhole defect in the packaging poses a risk to product sterility prior to implantation. No reported adverse events are mentioned in the source, making this a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Medicrea International is recalling 963 PASS LP cervical intervertebral fusion devices (REF numbers: B02315535Z, B02315540Z, B02315545Z, B02315550Z, B02316535Z, B02316540Z, B02316545Z, B02316550Z, B02317540Z, B02317545Z, and B02317550Z). The devices have been distributed nationwide.
The recall is due to a potential product packaging non-conformity issue characterized by pinholes in either the inner or outer pouch of the packaging. This defect may affect product integrity.
Specific lot numbers associated with each REF number are detailed in the FDA recall information. Healthcare providers and patients should consult the official recall notice to determine if their devices are affected and contact Medicrea International for instructions.
The recalled product
- Product
- 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
- Manufacturer
- Medicrea International
- Category
- Medical Device — Spinal Implant
- Hazard
- packaging-defect
- contamination-risk
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
Distribution
Distributed nationwide across the United States.
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