Reported Oct 28, 2015 · 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…
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?
- 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; Orthosis, Spinal, Pedicle fixation 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
- lot numbers
83 of 83 codes
472995148412094923651492365249876884987750535063520023303000595472995248412104923653492365449876834856248498775551538485153853160259618804894729953484121149236664923667498777848562754987761515982651573293016224472995448412124919162492366949877794856250498776651537963093619472995649236744987825498778050663634729958492361549878264987781506636447299594841213492365549362704987684498777151538495153854472996048353674923656
- Part numbers
- Amount recalled
- 492
Where it was sold
- Nationwide
Why it was recalled
This product was produced using a finishing process not identified as part of the manufacturing specification. The process used with the lots subject to this Recall was a bead blast process. (Bead Blasting vs. Shot Peened).
This product could cause temporary or reversible health problems — stop using it.
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