U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
데이터 추가 비고
Plate, fixation, bone - Product Code HRS
원인
Dimensional non-conformity of the thread on the screw head.
조치
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.
Worldwide Distribution - US TN only and Internationally to France and Switzerland
제품 설명
SCREW 02.7-12MM LOCKING, REF W27 ST112: a) DRP, b) NEO, 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