CLASS II Device recall · Reported 24 Jul 2013 · FDA Enforcement Report
Synthes CMF Distraction System The product is intended recalled
Synthes USA HQ is recalling Synthes CMF Distraction System The product is intended for use as a bone stabilizer and, distributed nationwide in the US. The recall was initiated on 12 Jun 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-1726-2013
- FDA event ID
- 65670
- Recalling firm
- Synthes USA HQ, West Chester, PA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 12 Jun 2013
- FDA classified
- 12 Jul 2013
- Reported
- 24 Jul 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 12 Jun 2013 | Recall initiated by company | |
| 12 Jul 2013 | Classified by FDA | +30 days |
| 24 Jul 2013 | Published in enforcement report | +12 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 initiated a voluntary recall of the BC Distractor Body which is part of the Craniomaxillofacial (CMF) Distractor System, due to a mis-alignment issue. There have been instances reported within the impacted lots in which the slot in the barrel of the BC distractor was rotated such that it was not possible to attach the B-type and C-type foot plates.
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
Synthes CMF Distraction System The product is intended for use as a bone stabilizer and lengthening (and/or transport) device for correction of congenital deficiencies or post-traumatic defects of the mandibular body and ramus, where gradual bone distraction is required. It is intended for single use only.
Where it was distributed
Nationwide Distribution including PA, CT, DE, and NY.
Questions about this recall
Is Synthes CMF Distraction System The product is intended for use as a bone stabilizer and recalled?
Yes. Synthes USA HQ recalled Synthes CMF Distraction System The product is intended for use as a bone stabilizer and on 12 Jun 2013. The recall is Class II and its status is Terminated. Recall number Z-1726-2013.
Why was it recalled?
The firm initiated a voluntary recall of the BC Distractor Body which is part of the Craniomaxillofacial (CMF) Distractor System, due to a mis-alignment issue. There have been instances reported within the impacted lots in which the slot in the barrel of the BC distractor was rotated such that it was not possible to attach the B-type and C-type foot plates.
Which lots are affected?
Part # 04.315.067 with lot #s 6184270 and/or 22612-04.
Where was it sold?
Nationwide Distribution including PA, CT, DE, and NY.
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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