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IBS - Osteosynthesis screws for bone fixation Model S25… recallZ-0397-2016 · In2Bones, SAS · initiated Nov 18, 2015

Class II Terminated All recalls posted in December 2015

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

One batch of osteosynthesis screws were manufactured with the incorrect Torx imprint on the screw head.

FDA root cause category: Nonconforming Material/Component

What the company is doing

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:[email protected].

Recall details

Recall number
Z-0397-2016
Recall class
Class II
Status
Terminated
Initiated by the company
Nov 18, 2015
Posted by the FDA
Dec 9, 2015
Recalling firm
In2Bones, SAS
Quantity
20 units
Product code
HWC
FDA submissions
K131920
Distribution
US Distribution to the state of :TN

Product description

IBS - Osteosynthesis screws for bone fixation Model S25 ST014.

Code information (models, lots, serial numbers)

1509058

Other devices under the same FDA submission

6 devices cleared under K131920 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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