Ortho OS Solutions UltOS 3.5mm locking screw 12mm to 50mm Ortho Solutions LTD, Unit 5 West Station Business Park, Spital

FDA device recall Z-0026-2016 · posted 2015-10-06 · Terminated

Recall details

Recalling firm

Ortho Solutions Inc

Reason for recall

Ortho Solutions Inc is initiating a recall on behalf of UltOS 3.5mm locking screw. The locking thread feature of the screw was not manufactured to specification. As a consequence there is a risk that a screw may not lock onto the plate at the time of primary insertion into the plate and the bone. In the event of this occurring the non functioning screw would need to be replaced with an alternativ

Action taken

The firm, Ortho Solutions Group, sent an "Urgent Medical Device Recall" notifications and "Effectiveness or Recall Declaration Forms" dated 14 July 2015. The notification informed the consignee of the issue, clinical risks, how to identify the affected product, and the actions the consignees were requested to take. Requested actions included reviewing product on-hand, ceasing distribution of affected product and arrangement for product to be returned to Ortho Solutions, Inc. within 2 working days. Consignees were also requested to fill out the Recall Declaration Form and return it to Ortho Solutions, Inc. via fax to: 201-335-0759 by 16 July 2015. If you should have any queries relating to this matter or require any additional information, contact General Manager at 201-906-6175.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

HWC

Quantity affected

875 units

Distribution

US Distribution to states of: CA, CO, GA, IL, LA, NC, NY, TX and WA.

Date initiated

2015-07-14

Date posted

2015-10-06

Date terminated

2017-04-26

Location

Mahwah, NJ

Related 510(k) clearances