Reported Mar 14, 2018 · Terminated
ACL DISPOSABLE PACK BONE-TENDON-BONE, Model 0234020280, labeled sterile.
Stryker Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Stryker Corporation · 5900 Optical Ct · San Jose, CA · 95138-1400
Is this the product you have?
- ACL DISPOSABLE PACK BONE-TENDON-BONE, Model 0234020280, labeled sterile.
- Lot codes and dates
Model 0234020280UDI 07613154643264Lot No. 17299AG2
- Amount recalled
- 60,753 units total
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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