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Stryker Corporation recalls STRYKER WEDGE INTERFERENCE SCREW SYSTEM, ACL Interface Screw, 9MM X 25MM, Model 0234010056, labeled sterile.
Recalled March 14, 2018 · FDA recall Z-0837-2018 · Stryker
Hazard
Routine bioburden testing of certain lots were found to have levels higher than internal acceptable rates. · FDA Class II
Units
60,753 units total
Sold at
Distributed domestically to . Distributed internationally to Australia and Mexico.
Description
Routine bioburden testing of certain lots were found to have levels higher than internal acceptable rates.
Product
STRYKER WEDGE INTERFERENCE SCREW SYSTEM, ACL Interface Screw, 9MM X 25MM, Model 0234010056, labeled sterile.
Manufacturer(s)
Stryker Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →