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
FDA Recall Z-0952-2017 · Posted 2017-01-06
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Recalling FirmIn2Bones, SAS
Recall StatusTerminated
Product CodeHRS
Date Initiated2016-12-19
Date Terminated2017-02-01
Product Quantity19 units
Reason for Recall
Dimensional non-conformity of the thread on the screw head.
Firm Action
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:
[email protected].
For questions regarding this recall call 844-602-6637.
Root Cause
Component design/selection
Distribution Pattern
Worldwide Distribution - US TN only and Internationally to France and Switzerland
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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