Reported Jul 13, 2016 · Terminated
Synthes Ti Button Plate 7 Holes, Fastener, Fixation, nondegradable, Soft Tissue
Synthes (USA) Products LLC
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) Products LLC · 1301 Goshen Pkwy · West Chester, PA · 19380-5986
Is this the product you have?
- Synthes Ti Button Plate 7 Holes, Fastener, Fixation, nondegradable, Soft Tissue
- Lot codes and dates
- Lot Numbers
126 of 126 codes
174914818963493057585312647432775873527962366697937231493754359375436038002373800239382549841823644182365418423841842394184240418424141861564186158418615942018664201867420186842052884872583489415648941574931671493167249316734952212499223749928365004334508306751063495115240511524151270395153048515304953284965337095533981953443475369177539126754047495450581548508255105605510561551056255105635510564551056555831887554579
- Part Numbers482.823
- Device Listing NumberD194880
- Lot Numbers
- Amount recalled
- 6,255 units
Where it was sold
Why it was recalled
DePuy Synthes is voluntarily initiating a recall due to affected devices being distributed and or labeled with MR Safety information that does not meet the current ASTM standard.
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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