Reported Jul 24, 2013 · Terminated
Synthes CMF Distraction System The product is intended for use as a bone stabilizer and lengthening (and/or transport)…
Synthes USA HQ, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Synthes USA HQ, Inc. · 1302 Wrights Ln E · West Chester, PA · 19380-3417
Is this the product you have?
- 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.
- Lot codes and dates
- Part # 04.315.067 with lot #s 6184270 and/or 22612-04.
- Amount recalled
- 10
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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