Amendia, Inc dba Spinal Elements Piranha Screw 4.0 x 12mm, used in Piranha Surgical Plate recall — FDA Z-0239-2018
Potential incorrect marking and color identification of Piranha screw. Some screws marked as 12 mm actually measure 14 mm.
Overview of recall records associated with Amendia, Inc dba Spinal Elements, including dates, categories and classifications where available.
Classification mix: Class II: 1.
Potential incorrect marking and color identification of Piranha screw. Some screws marked as 12 mm actually measure 14 mm.
This page summarizes recall records in which the official source identifies Amendia, Inc dba Spinal Elements 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.