Reamer

RIA Tube Assembly, minimum 520 mm length, sterile- intended for use in adults and adolescents (12-21 years) to clear the medullary canal of bone marrow and deb

Products not sterilized, sterility cannot be confirmed

Identity Shoulder System Resection Planer 35mm Resection Planer

Two planers were found to be unusable during sawbones shoulder training.

Synthes Flexible Shaft, Orthopedic manual surgical instrument

Non-conforming material used.

2.5 mm Reaming Rod with Ball Tip & Extension/950 mm, Sterile

The peel pouches for the affected reaming rods and extraction hooks are delaminating.

3.0 mm Reaming Rod/950 mm, Sterile

The peel pouches for the affected reaming rods and extraction hooks are delaminating.

3.0 mm Guide Rod/950 mm with Smooth Tip, sterile

The peel pouches for the affected reaming rods and extraction hooks are delaminating.

2.5 mm Guide Rod w/Smooth Tip 950 mm, Sterile

The peel pouches for the affected reaming rods and extraction hooks are delaminating.

2.5 mm TI Calibrated Reaming Rod 850 mm, Sterile

The peel pouches for the affected reaming rods and extraction hooks are delaminating.

2.5 mm Reaming Rod W/Ball Tip 650 mm, Sterile

The peel pouches for the affected reaming rods and extraction hooks are delaminating.

DePuy Synthes 8.0 mm Flexible Shaft Reamer, 360 mm, Orthopedic manual surgical instrument. Part number 351.43

Devices did not pass the biological safety evaluation for cytotoxicity following exposure to test conditions. The high growth inhibition levels observed during testing could be attributed to corrosion of the device at solder points. This could potentially be reproduced during use and reprocessing.