NEO SCREW 02.7-14MM LOCKING, REF W27 ST114, In2Bones, 28 chemin du petit bois, 69130 Ecully - France The NEOVIEW Plating System is intended for fixation of intra-articular and extraarticular fractures of the distal radius and reconstruction of the distal radius
This recall has been terminated (originally issued January 6, 2017).
- Recall Initiated
- December 19, 2016
- Posted
- January 6, 2017
- Terminated
- February 1, 2017
- Recall Number
- Z-0953-2017
- Quantity
- 40 units
- Official Source
- View on FDA website ↗
Reason for Recall
Dimensional non-conformity of the thread on the screw head.
Distribution
Worldwide Distribution - US TN only and Internationally to France and Switzerland
Lot / Code Info
Lot Numbers: 1604154, 1605083, 1606068
Root Cause
Component design/selection
Action Taken
IN2BONES en a Field Safety Corrective Action letter dated December 15, 2016, to the sole US distributor. The letter identified the product, the problem, and the action to be taken by the customer. We therefore recommend you to follow the instructions here below: 1. Identify all the devices with the batches subject of this recall that might still be in your inventory and quarantine them 2. Inform and distribute this Recall Notification to all relevant persons within your organization 3. To distributors only: Identify all the devices with the batches subject of this recall that were delivered to your customers, and if relevant, instruct them to also follow these instructions (identification and quarantine) 4. Fill in and return the fax back form enclosed. With this form, you will certify that you have received this Recall Notification and intend to comply with the recommendations listed. This fax back form will enable In2Bones to conduct effectiveness checks. Customers with questions were instructed to contact the Quality and Regulatory Affairs team at +33 4 72 29 26 26 / +33 7 61 88 44 30 or by email: qualte@in2bones.com. For questions regarding this recall call 844-602-6637.