FDAMarch 19, 2019device
Performance Series Sagittal Blade, Catalog Number 6125-127-100 Product Usage: The Stryker Heavy Duty Sagittal Blades are used in the cutting and shaping of bone and other bone related tissue in various orthopedic procedures. Typical procedures include, total-knee, uni-compartmental knee, hip, sho...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
During manufacture, packaging materials for a small portion of the lot may not have been properly positioned, resulting in a potential breach in sterility.
What to do
FDA enforcement status: Terminated
Brands named
stryker instruments divstrykerstryker instruments
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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- FDABARD Dynamic XT Steerable, Product Number 201104; REPROCESSED ELECTROPHYSIOLOGY CATHETER2026-04-10
- FDABW Webster Duo-Decapolar, Product Number D728260RT; REPROCESSED ELECTROPHYSIOLOGY CATHETER2026-04-10
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