FDA-Device2018-03-14Class II
ACL DISPOSABLE PACK BONE-TENDON-BONE, Model 0234020280, labeled sterile.
Stryker Corporation
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.
Sold states
Distributed domestically to . Distributed internationally to Australia and Mexico.
Affected count
60,753 units total
Manufactured in
5900 Optical Ct, N/A, San Jose, CA, United States
Products
ACL DISPOSABLE PACK BONE-TENDON-BONE, Model 0234020280, labeled sterile.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0838-2018Don't want to check this manually?
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