Reported Jul 22, 2015 · Terminated
Reamer / Irrigator / Aspirator (RIA): RIA Drive Shafts, RIA Tube Assemblies, sterile, RIA Reamer Head, sterile…
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?
- Reamer / Irrigator / Aspirator (RIA)RIA Drive Shafts, RIA Tube Assemblies, sterile, RIA Reamer Head, sterile (12.0mm-19.0mm); intended to clear the medullary canal of bone marrow and debris and to effectively size the medullary canal for the acceptance of an intramedullary implant or prosthesis
- Lot codes and dates
- Part numbers
314.742 and 314.743314.745S and 314.746S352.250S-352.265S
- all lot numbers
3,006 of 3,006 codes
434576045212624546058468559646855995017013507231650818235086873509492951082685134954513497051349815134985514057951405805229647525545053097875349578535042453514195373244540208454231905525258552772155533755585914560389156615445666966570653660221476027929605408260738436098786620137762144066290254630312463050436367680642095764324776648785700494570333607061003708194070819417353279735328074040167455951748454915990-0116442-01
- Part numbers
- Amount recalled
- 132564
Where it was sold
- Nationwide
Why it was recalled
It was reported that the RIA Drive Shaft, Tube Assembly, and Reamer Head have the potential to break when incorrectly assembled or used improperly. Precautionary statements are being added to the Reamer / Irrigator / Aspirator (RIA) Surgical Technique Guide .
This product could cause temporary or reversible health problems — stop using it.
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