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Recall Observatory FDA recall evidence

Device product

Co-Cr cancellous bone screw,15mm Co-Cr cancellous bone screw,20mm Co-Cr cancellous bone screw,25mm Co-Cr cancellous bone screw,30mm Co-Cr cancellous bone screw,35mm Co-Cr cancellous bone screw,40mm Variety of hip and knee implants and instruments, multiple uses.

Z-1384-2013

February 20, 2013

Class II

Product summary

Firm
Orthopedic Alliance LLC
Event
Event 64588
Status
Terminated
Classification
Class II
Quantity
5 units
Official record key
device-enforcement:Z-1384-2013

Official wording

Reason: The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Orthopedic Alliance because the directions for use and surgical techniques were not being provided to every physician and for every surgery.

Code information: Item No. 5201-6715 5201-6720 5201-6725 5201-6730 5201-6735 5201-6740

Distribution pattern: Nationwide Distribution including the states of CA, MD, TX, NV, and WI.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Orthopedic Alliance because the directions for use and surgical techniques were not being provided to every physician and for every surgery.