Reported Feb 4, 2015 · Terminated
The Synthes Mandible External Fixator; all lots of part nos.: 04.305.003 04.305.004 04.305.005 04.305.010 04.305.011…
Synthes, 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, Inc. · 1302 Wrights Ln E · West Chester, PA · 19380-3417
Is this the product you have?
- The Synthes Mandible External Fixator; all lots of part nos.:Intended to stabilize and provide treatment for fractures of the maxillofacial area, including severe open mandibular fractures, highly comminuted closed fractures, nonunions and delayed unions (especially associated with infection), fractures associated with infections, tumor resections, facial deformity corrections, gunshot wounds, pan facial fractures, burn maintenance, and bone grafting defects.
04.305.00304.305.00404.305.00504.305.01004.305.01104.305.01203.305.00604.305.10004.305.10104.305.10204.305.10304.305.12804.305.13004.305.13404.305.13804.305.14004.305.14203.305.10503.305.50003.305.500S
- Lot codes and dates
- All lots of part nos.:
04.305.00304.305.00404.305.00504.305.01004.305.01104.305.01203.305.00604.305.10004.305.10104.305.10204.305.10304.305.12804.305.13004.305.13404.305.13804.305.14004.305.14203.305.105
- All lots of part nos.:
- Amount recalled
- 43159
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Why it was recalled
Under new testing protocols for MR Environment safety and compatibility, metal devices are no longer designated MR Safe. Some components in the CMF Mandible External Fixator Systems were labeled and/or etched with information indicating they are MR Safe. They can no longer be labeled MR Safe.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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