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
Screw, fixation, bone - Product Code HWC
원인
One batch of osteosynthesis screws were manufactured with the incorrect torx imprint on the screw head.
조치
IN2Bones - USA sent an Field Safety Corrective Action Medical Device Batch Recall letter dated November 17, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.
Recommended actions :
We therefore you to follow the instructions here below:
1. Identify all I.B.screws 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 I.B.screws 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 ln2Bones to conduct effectiveness checks.
For any question,plea1se contact our Quality and Regulatory Affairs team at: +33 4 72 29 26 26/ +33 7 6188 44 30 or by email:qualite@in2bones.com.