Reported Dec 4, 2013 · Terminated
Slipped Capital Femoral Epiphysis System Product Usage: Intended for fracture fixation of large bones and large bone…
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?
- Slipped Capital
- Femoral Epiphysis System Product UsageIntended for fracture fixation of large bones and large bone fragments and for slipped capital femoral epiphysis, pediatric femoral neck fractures, intercondylar femur fractures and sacroiliac joint disruptions
- Lot codes and dates
- Parts 03.207.001 and 03.207.008
- with lot numbersPart # Lot #
03.207.001PE00376PE00439PE01391PE01329PE01412PE0050403.207.008PE00440PE00377PE00513PE01475PE01691
- Amount recalled
- 166
This recall covers 16 products
The agency filed one notice per product. You are reading one of them; the other 15 are below.
3 more are in the archive.
Where it was sold
- Nationwide
Why it was recalled
There is a possibility for the Guide Wires of the Slipped Capital Femoral Epiphysis System to stick in the cannulation of the drill bit and the drill bits to break during surgery.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
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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