CLASS II Device recall · Reported 4 Dec 2013 · FDA Enforcement Report
and Dynamic Locking Screw (DLS) recalled by Synthes USA HQ
Synthes USA HQ is recalling and Dynamic Locking Screw (DLS), distributed nationwide in the US. The recall was initiated on 22 Jul 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-0390-2014
- FDA event ID
- 66666
- Recalling firm
- Synthes USA HQ, West Chester, PA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 22 Jul 2013
- FDA classified
- 25 Nov 2013
- Reported
- 4 Dec 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 22 Jul 2013 | Recall initiated by company | |
| 25 Nov 2013 | Classified by FDA | +126 days |
| 4 Dec 2013 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
All lots of 3.7mm and 5.0mm Dynamic Locking Screw (DLS) were recalled due to complaints of breakages at the distal tip of the pin identified after successful healing and during planned removal of the device.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
3.7mm and 5.0mm Dynamic Locking Screw (DLS) Product Usage: 3.7mm and 5.0mm Dynamic Locking Screw (DLS) in combination with Synthes Locking Compression Plates (LCP) are intended for use in long bone fractures, the fixation of osteopenic bone, the fixation of osteotomies, and for the fixation of non-unions and malunions.
Where it was distributed
Worldwide Distribution - USA (nationwide) and internationally to Canada.
Questions about this recall
Is and Dynamic Locking Screw (DLS) recalled?
Yes. Synthes USA HQ recalled and Dynamic Locking Screw (DLS) on 22 Jul 2013. The recall is Class II and its status is Terminated. Recall number Z-0390-2014.
Why was it recalled?
All lots of 3.7mm and 5.0mm Dynamic Locking Screw (DLS) were recalled due to complaints of breakages at the distal tip of the pin identified after successful healing and during planned removal of the device.
Which lots are affected?
All lots of parts 09.213.022S - 09.213.070S, and 09.223.032S- 09.223.090S.
Where was it sold?
Worldwide Distribution - USA (nationwide) and internationally to Canada.
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.
More recalls from Synthes USA HQ
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|---|---|---|---|---|---|
| Device | CLASS II | Synthes Hand Switch - Electric Pen Drive recalled by Synthes USA HQ | Synthes USA HQ | Foreign Material | Nationwide |
| Device | CLASS II | Synthes TomoFix Plates The Synthes J5606-C TomoFix recalled | Synthes USA HQ | Other | Nationwide |
| Device | CLASS II | Synthes Trochanteric Fixation Nail As part of the Synthes recalled | Synthes USA HQ | Labeling Errors | Nationwide |
| Device | CLASS II | Synthes Soft Tissue Retractor Small Extendible recalled | Synthes USA HQ | Device Malfunction | Nationwide |
| Device | CLASS II | Titanium Trochanteric Fixation Nail recalled by Synthes USA HQ | Synthes USA HQ | Other | Nationwide |
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