Z-1383-2013 Class II Terminated
FDA device recall Z-1383-2013 was initiated by Orthopedic Alliance LLC on February 20, 2013 and is designated Class II. Reason for recall: 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… The recall status is terminated (terminated March 26, 2014). Affected quantity: 37 units.
Recall Details
- Product Type
- Devices
- Report Date
- June 5, 2013
- Initiation Date
- February 20, 2013
- Termination Date
- March 26, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 37 units
Product Description
Bipolar Cap, ID26mm, OD42mm Bipolar Cap, ID28mm, OD44mm Bipolar Cap, ID28mm, OD46mm Bipolar Cap, ID28mm, OD48mm Bipolar Cap, ID28mm, OD50mm Bipolar Cap, ID28mm, OD52mm Bipolar Cap, ID28mm, OD54mm Bipolar Cap, ID28mm, OD56mm
Reason for Recall
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.
Distribution Pattern
Nationwide Distribution including the states of CA, MD, TX, NV, and WI.
Code Information
Item No. 1503-3042 1503-3144 1503-3146 1503-3148 1503-3150 1503-3152 1503-3154 1503-3156