Stryker Recalls ACL Interface Screws Due to Bioburden Levels
Stryker is recalling specific lots of ACL Interface Screws because routine testing found bioburden levels higher than internal acceptable rates.
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: The recall is classified as FDA Class II and involves a risk-of-harm product (sterile implant) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Stryker Corporation is recalling the STRYKER WEDGE INTERFERENCE SCREW SYSTEM, specifically the ACL Interface Screw, 9MM X 25MM, Model 0234010056. The recall involves 60,753 units labeled as sterile. The specific lot affected is Lot No. 17278AG2, with UDI 04546540754561.
The recall was initiated because routine bioburden testing of certain lots revealed levels higher than the company's internal acceptable rates. The FDA has classified this as a Class II recall. The products were distributed domestically and internationally to Australia and Mexico.
Healthcare providers and facilities should stop using the affected lots immediately. Consumers and patients who have had these specific screws implanted should contact their healthcare provider for guidance on next steps.
The recalled product
- Product
- STRYKER WEDGE INTERFERENCE SCREW SYSTEM, ACL Interface Screw, 9MM X 25MM, Model 0234010056, labeled sterile.
- Manufacturer
- Stryker Corporation
- Hazard
- Affected units
- 60,753
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 (3)
- Model 0234010056
- UDI 04546540754561
- Lot No. 17278AG2
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 4 recalled by 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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