Stryker Wedge Interference Screw System recall
STRYKER WEDGE INTERFERENCE SCREW SYSTEM, ACL Interface Screw, 9MM X 25MM, Model 0234010056, labeled sterile.
Why was Stryker Wedge Interference Screw System recalled?
Routine bioburden testing of certain lots were found to have levels higher than internal acceptable rates.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Model 0234010056, UDI 04546540754561, Lot No. 17278AG2
- Product
- STRYKER WEDGE INTERFERENCE SCREW SYSTEM, ACL Interface Screw, 9MM X 25MM, Model 0234010056, labeled sterile.
- Recalling firm
- Stryker Corporation
- Quantity
- 60,753 units total
- Distribution
- Distributed domestically to . Distributed internationally to Australia and Mexico.
- Recall date
- March 14, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)