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Neoview(R) Screws Set, Ref W27 St900, Sterile R recallZ-0954-2017 · In2Bones, SAS · initiated Dec 19, 2016

Class II Terminated All recalls posted in January 2017

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from In2Bones, SAS or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Dimensional non-conformity of the thread on the screw head.

FDA root cause category: Component design/selection

What the company is doing

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.

Recall details

Recall number
Z-0954-2017
Recall class
Class II
Status
Terminated
Initiated by the company
Dec 19, 2016
Posted by the FDA
Jan 6, 2017
Recalling firm
In2Bones, SAS
Quantity
26 units
Product code
HRS
FDA submissions
K160995
Distribution
Worldwide Distribution - US TN only and Internationally to France and Switzerland

Product description

NEOVIEW(R) SCREWS SET, REF W27 ST900, STERILE R The NEOVIEW Plating System is intended for fixation of intra-articular and extraarticular fractures of the distal radius and reconstruction of the distal radius

Code information (models, lots, serial numbers)

Lot number 1602134

Other devices under the same FDA submission

1 device cleared under K160995 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 76104).

Sources and updates

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