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Stryker Corporation recalls ACL DISPOSABLE PACK BONE-TENDON-BONE, Model 0234020280, labeled sterile.
Recalled March 14, 2018 · FDA recall Z-0838-2018 · Stryker
Hazard
Routine bioburden testing of certain lots were found to have levels higher than internal acceptable rates. It is indicated to be a single surgery use, disposable set of instrumentation for anterior cruciate ligament (ACL) reconstruction surgeries. · 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. It is indicated to be a single surgery use, disposable set of instrumentation for anterior cruciate ligament (ACL) reconstruction surgeries.
Product
ACL DISPOSABLE PACK BONE-TENDON-BONE, Model 0234020280, labeled sterile.
Manufacturer(s)
Stryker Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →