Reported Aug 21, 2013 · Terminated
5.0mm Unit Rod 270mm 5.0mm Unit Rod 290mm 5.0mm Unit Rod 310mm 5.0mm Unit Rod 330mm 5.0mm Unit Rod 350mm 5.0mm Unit Rod…
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?
- 5.0mm Unit Rod 270mm 5.0mm Unit Rod 290mm 5.0mm Unit Rod 310mm 5.0mm Unit Rod 330mm 5.0mm Unit Rod 350mm 5.0mm Unit Rod 370mm 5.0mm Unit Rod 390mm 5.0mm Unit Rod 410mm 5.0mm Unit Rod 430mm 5.0mm Unit Rod 450mm pedicle screw spinal system; Intended to provide immobilization and stabilization of spinal segments in skeletally mature patients.
- Lot codes and dates
- Part Numbers
298.269298.270298.271298.272298.273298.274298.275298.276298.277298.278
- with lot numbers
74 of 74 codes
472995148412094923651492365249876884987750535063520023303000595 47299524841210492365349236544987683485624849877555153848515385316025961880489 4729953484121149236664923667498777848562754987761515982651573293016224 472995448412124919162492366949877794856250498776651537963093619 47299564923674498782549877805066363 47299584923615498782649877815066364 47299594841213492365549362704987684498777151538495153854 472996048353674923656492365749849824856246498777251598275157330 47299614835368
- Part Numbers
- Amount recalled
- 492
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
- Nationwide
Why it was recalled
DePuy Synthes has issued a Medical Device Correction notice for the 5.0mm Stainless Steel rods. This product was produced using a finishing process not identified as part of the manufacturing specification. No adverse event reports associated with the use of this product were received, and an extensive engineering and medical safety review concluded that the product poses no incremental risk to t
This product could cause temporary or reversible health problems — stop using it.
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