FDA Device recall Z-1726-2013
Synthes CMF Distraction System The product is intended for use as a bone stabilizer and lengthening (and/or transport) device for correctio…
- FDA Device
- Class II
- terminated
- Published 2013-07-24
On 2013-07-24 the FDA classified a Class II recall of Synthes CMF Distraction System The product is intended for use as a bone stabilizer and lengthening (and/or transport) device for correctio… by Synthes Usa Hq, citing 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 ins….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1726-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-06-12 |
| Published | 2013-07-24 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Synthes Usa Hq |
| Distribution | US |
Product
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.
Reason
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.
Identifiers
| code_info | Part # 04.315.067 with lot #s 6184270 and/or 22612-04. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1726-2013%22
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