Smith & Nephew smith&nephew LEGION(R) CR XLPE HIGH LEXION Articular Insert, 1-2 Size, 9 MM recall — FDA Z-1907-2018
The affected products were inadvertently packaged with the inner packaging pouch being sealed together with the outer pouch.
Overview of recall records associated with Smith & Nephew, Inc., including dates, categories and classifications where available.
Classification mix: Class II: 124.
The affected products were inadvertently packaged with the inner packaging pouch being sealed together with the outer pouch.
Packaging design is insufficient to prevent potential sterile barrier breach (pin hole) in Tyvek film of pouch. A limited number of previously recalled devices were inadvertently…
One lot of D-RAD Self-Taping Locking Screws used with the Distal Radius Fracture Kit were machined out of specification. Screws measured over tolerance within the head thread form by…
The screws package with devices within lot 14AAP6352A were 5 MM instead of 10MM and are too short to be used with the Legion HK Distal Wedge Size 5.
This page summarizes recall records in which the official source identifies Smith & Nephew, Inc. as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.