Stryker Recalls Collagen Meniscus Implants Due to Temperature Packaging Defect
Stryker is recalling 155 Collagen Meniscus Implants shipped to the Netherlands without required temperature control packaging, potentially exposing them to elevated temperatures.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard is a potential exposure to elevated temperatures due to missing packaging, which is a precautionary measure without reported injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Stryker Corporation is recalling 155 units of the CMI (Collagen Meniscus Implant) device, a collagen-based meniscus implant manufactured by Ivy Sports Medicine. The recall is limited to devices distributed in the Netherlands.
The recall was initiated because the products were shipped without the required temperature control packaging. This defect means the devices could potentially have been exposed to elevated temperatures during transit, which may compromise the integrity of the bovine type I collagen material.
Patients who have received this implant should contact their healthcare provider for evaluation. The specific serial and lot numbers affected are listed in the official recall documentation.
The recalled product
- Product
- CMI (Collagen Meniscus Implant) device, Ivy Sports Medicine s collagen-based meniscus implant Product Usage: The CMI device, Ivy Sports Medicine s collagen-based meniscus implant, is comprised primarily of bovine type I collagen (nominally 99%) derived from tendon and small q
- Manufacturer
- Stryker Corporation
- Affected units
- 155
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 (15)
- Serial/Lot Number(s) Affected: 4600: 15J456
- 4601: 16A463
- 16G470
- 17F510
- 4607: 16A461
- 16D465
- 16E467
- 16F468
- 17E506
- 17E507
- 4612: 16A458
- 16A459
- 17D489
- 17E503
- 17E504
Distribution
Distribution scope not specified by the agency.
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