One acl director angled bullet assembly used for treatment, was not returned for evaluation.Due to product unavailability, evaluation was limited.The information provided states, ¿the blt assy angled director acl and the 4 point director had the calibration no longer legible¿.An exact root cause cannot be determined with confidence.Instruction for use documentation contains precautionary statements and recommendations for proper use of product.Per instruction for use: prior to use, inspect the device to ensure it is not damaged.Do not use a damaged device.Insert the bullet into the bottom of the guide with the flat side of the bullet knob facing down.Complaint history review indicated, no other complaints of this failure was found.Batch review was unattainable without a valid lot number reported.No indications suggest the product did not meet specifications upon release to distribution.
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