IBS - Osteosynthesis screws for bone fixation Model S25 ST014.

FDA device recall Z-0397-2016 · posted 2015-12-09 · Terminated

Recall details

Recalling firm

In2Bones, SAS

Reason for recall

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

Action taken

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.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

HWC

Quantity affected

20 units

Distribution

US Distribution to the state of :TN

Date initiated

2015-11-18

Date posted

2015-12-09

Date terminated

2016-08-19

Location

Ecully, France

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