CLASS II Device recall · Reported 20 Nov 2013 · FDA Enforcement Report
Locking Screw, T15 Hexalobe recalled by OrthoPediatrics
OrthoPediatrics is recalling Locking Screw, T15 Hexalobe, Self Tapping The OrthoPediatrics Proximal Femur Plating, distributed in Michigan. The recall was initiated on 26 Sep 2013 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0276-2014
- FDA event ID
- 66450
- Recalling firm
- OrthoPediatrics, Warsaw, IN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 26 Sep 2013
- FDA classified
- 14 Nov 2013
- Reported
- 20 Nov 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Labeling Errors
- Device type
- Heart & Vascular Devices
Timeline
| 26 Sep 2013 | Recall initiated by company | |
| 14 Nov 2013 | Classified by FDA | +49 days |
| 20 Nov 2013 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The firm identified, through complaints that the 3.5MM LOCKING SCREW packaging material was marked as a 3.5mm screw and the part number was correct but that the description indicated a 7.0mm screw. Upon investigation, it has been determined that a lot number 009U2 was packaged and mislabeled internally by OrthoPediatrics.
Product as listed by the FDA
3.5MM LOCKING SCREW, T15 HEXALOBE, SELF TAPPING, 34MM The OrthoPediatrics Proximal Femur Plating System combines implants and instruments in one convenient system. This system offers the advantages of the osteotomy blade plates and cannulated instrumentation. Osteotomy plates provide ease of reduction and good rotational stability while maintaining bone stock. Cannulated instruments work over a guide wire for precise placement and safety. The subject device is a Bone Screw designed for use with this system.
Where it was distributed
Worldwide Distribution - US including Michigan and the countries of Ireland and Australia
Questions about this recall
Is Locking Screw, T15 Hexalobe, Self Tapping The OrthoPediatrics Proximal Femur Plating recalled?
Yes. OrthoPediatrics recalled Locking Screw, T15 Hexalobe, Self Tapping The OrthoPediatrics Proximal Femur Plating on 26 Sep 2013. The recall is Class II and its status is Terminated. Recall number Z-0276-2014.
Why was it recalled?
The firm identified, through complaints that the 3.5MM LOCKING SCREW packaging material was marked as a 3.5mm screw and the part number was correct but that the description indicated a 7.0mm screw. Upon investigation, it has been determined that a lot number 009U2 was packaged and mislabeled internally by OrthoPediatrics.
Which lots are affected?
Part Number:. 00-0903-2634 and lot number 009U2
Where was it sold?
Worldwide Distribution - US including Michigan and the countries of Ireland and Australia
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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