Medicrea International Medicrea, IB3D PL Instruments Set, Rx Only REF: SPS03174 recall — FDA Z-1039-2026
Due to complaints, orthopedic rotation tool handle may untread from the shaft resulting in the inability to rotate implant.
Overview of recall records associated with Medicrea International, including dates, categories and classifications where available.
Classification mix: Class II: 16.
Due to complaints, orthopedic rotation tool handle may untread from the shaft resulting in the inability to rotate implant.
Due to complaints, orthopedic rotation tool handle may untread from the shaft resulting in the inability to rotate implant.
Due to software anomalies that may impact on rod planning specifically, certain optional surgical parameters may have had errors that resulted i incorrect calculations displayed on system.…
There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch.
There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch.
There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch.
There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch.
There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch.
There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch.
There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch.
There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch.
There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch.
Tightening the LIGAPASS Band with this instrument, the tensioner's pliers can crush the band causing the band to break during surgery and lead to a risk of infection and re-intervention ,
An internal component was assembled in the incorrect orientation, which may lead to the tulip head disengaging from the crew shank during or after screw insertion, or during the reduction…
An internal component was assembled in the incorrect orientation, which may lead to the tulip head disengaging from the crew shank during or after screw insertion, or during the reduction…
It has been determined that some Pedicle system screw identified as 45mm long have an actual length of 50mm. Pedicle screws with a diameter of 7.5 mm or more are reserved for the sacrum…
This page summarizes recall records in which the official source identifies Medicrea International 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.