Reamer / Irrigator / Aspirator (RIA): RIA Drive Shafts, RIA Tube Assemblies, sterile, RIA Reamer Head, sterile
Medical device recall Z-2092-2015. Published in FDA’s Enforcement Report on Jul 22, 2015.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Jul 22, 2015. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 132564 how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
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 .
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
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
132564, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Part numbers: 314.742 and 314.743; 314.745S and 314.746S; 352.250S-352.265S, all lot numbers:4345760 4521262 4546058 4685596 4685599 5017013 5072316 5081823 5086873 5094929 5108268 5134954 5134970 5134981 5134985 5140579 5140580 5229647…
Every code shown here, 1,997 characters
Part numbers: 314.742 and 314.743; 314.745S and 314.746S; 352.250S-352.265S, all lot numbers:4345760 4521262 4546058 4685596 4685599 5017013 5072316 5081823 5086873 5094929 5108268 5134954 5134970 5134981 5134985 5140579 5140580 5229647 5255450 5309787 5349578 5350424 5351419 5373244 5402084 5423190 5525258 5527721 5553375 5585914 5603891 5661544 5666966 5706536 6022147 6027929 6054082 6073843 6098786 6201377 6214406 6290254 6303124 6305043 6367680 6420957 6432477 6648785 7004945 7033360 7061003 7081940 7081941 7353279 7353280 7404016 7455951 7484549 15990-01 16442-01 4345755 4352274 4503423 4548807 4685603 4685604 4757748 4760853 5019101 5020041 5020042 5109277 5110260 5110261 5145363 5147873 5150052 5152434 5152576 5152577 5167593 5202031 5226297 5236556 5260781 5260782 5260783 5282283 5283188 5309788 5349601 5366405 5374205 5408910 5423185 5434205 5442581 5459053 5471386 5574677 5585069 5588728 5597139 5602756 5623131 5626347 5634095 5639589 5655433 5672721 5682359 5815897 5816844 5816845 5817745 5820780 5822277 5832876 5832877 5836021 5843459 5846618 5846620 5867802 5873442 5889651 6021799 6109339 6124872 6168026 6168914 6170566 6170567 6170568 6170569 6170570 6170571 6187958 6296945 6299766 6299767 6648786 6718729 6793380 6857086 6877108 6897961 6921237 6921238 6940098 6961145 7004946 7061004 7128719 7201764 7312607 7312609 7353281 7353282 7353283 7404017 7432391 7432392 7432393 7455952 7757325 7773993 15803-01 15804-01 15806-01 15808-01 16304-01 16658-01 4730095 4814913 4875956 4922541 4942997 4942998 4942999 4943001 4997863 5049500 5049501 5049502 5049503 5141510 5165537 5182257 5200074 5242295 5265378 5265379 5265380 5265381 5265382 5473212 5473213 5494400 5494401 5582453 5595079 5628794 5629213 5629214 5629544 5629545 5732527 5786883 5828545 5892894 6042167 6042168 6082116 6082117 6144601 6181337 6181338 6266118 6363509 6452120 6500566 6500567 6554180 6558000 6558001 6568688 6592477 6592478 6592479 6592480 6595789 6625075 6625076 6625077 6649225 6649226…
FDA’s list runs to 24,148 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
Nationwide Distribution and Internationally to Canada and Switzerland.
These words name no state.
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on May 28, 2015.
- FDA classified it on Jul 16, 2015.
- FDA’s Enforcement Report published it on Jul 22, 2015.
- FDA terminated it on Aug 18, 2016.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Synthes, Inc., of West Chester, PA.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 24,148 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.