Ratcheting Torque Limiting Handle, Catalog Number 52-1012, Orthofix Spinal Implants, Firebird Spinal Fixation System, Firebird Spinal Fixation System DDD Instrument Case. Product is intended for use with the Set Screw Driver (52-1061) and Adjustable Counter Torque Wrench (52-1265) to perform the final tightening of set screws in a spinal implant construct.
This recall has been terminated (originally issued September 7, 2011).
- Company
- Orthofix, Inc
- Recall Initiated
- April 1, 2011
- Posted
- September 7, 2011
- Terminated
- March 23, 2012
- Recall Number
- Z-3162-2011
- Quantity
- 287 units
- Firm Location
- Lewisville, TX
- Official Source
- View on FDA website ↗
Reason for Recall
Upon reaching torque limit, there is a possibility the product may jam or exhibit a ratchet direction switch from forward to reverse.
Distribution
Worldwide Distribution-USA (nationwide) and Puerto Rico and the countries of Australia and Germany.
Lot / Code Info
All serial numbers.
Root Cause
Device Design
Action Taken
Orthofix, Inc. sent an "URGENT PRODUCT RECALL NOTIFICATION" letter dated April 1, 2011 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers. The letter instructs customers to identify and remove the affected product from use. Customers were advised to use the combination of the Ratching R Handle and the Set Screw Driver if they experience problems with the Ratching Torque Limiting Handle. A Tracking and Verification form was attached for customers to complete and return to the Orthofix Inc. Regulatory Affairs Department via fax at 214-937-3322. Contact your Account Services Representative at 888-298-5700 for questions regarding the removal and return of the affected product.