Stryker Recalls 11g Verteport Cement Cannula Due to Sterility Concerns
Stryker is recalling 11g Verteport Cement Cannulas because bioburden levels were found to be higher than acceptable rates, potentially compromising sterility.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II. Per the rubric, FDA Class II recalls involving significant injury/property-damage reports or high-risk contexts (like sterility failure in invasive devices) align with a Severe rating, especially given the potential for serious infection.
Plain-English summary
Stryker Instruments Div. of Stryker Corporation is recalling 900 units of the 11g Verteport Cement Cannula (18/pkg), Product Number 0306-511-000, UDI (01)7613252594307. The product is intended for spinal orthopedic use. The recall was initiated because bioburden levels were found to be higher than internal acceptable rates, indicating a lack of sterility assurance.
The affected units, identified by Lot Number 17278012, were distributed in all 50 U.S. states and the District of Columbia. They were also distributed in Australia, Argentina, Japan, Canada, Chile, Korea, Spain, France, Italy, the Netherlands, and the United Kingdom.
Healthcare facilities and distributors should stop using the affected product and contact Stryker for further instructions. Patients who have received this device should consult their healthcare provider if they have concerns regarding sterility or potential infection.
The recalled product
- Product
- 11g Verteport Cement Cannula (18/pkg), Product Number: 0306-511-000, UDI: (01)7613252594307 for spinal orthopedic use.
- Manufacturer
- Stryker Instruments Div. of Stryker Corporation
- Affected units
- 900
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 (1)
- Lot Number: 17278012 UDI: (01)7613252594307
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 13 recalled by Stryker Instruments Div. of Stryker Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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