The Acumed Slide-Loc Anatomic Radial Head System is intended for use by surgeons with orthopedic training
Medical device recall Z-2197-2017. Published in FDA’s Enforcement Report on Jun 7, 2017.
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 Jun 7, 2017. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word, and 35 states named
- 13076 parts total (8373 units of parts/instruments and 4703 units of implantable parts) 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?
The firm initiates a voluntary removal and discontinue marketing of Slide-Loc Anatomic Radial Head System based on its performance in the market. The firm received product complaints regarding instrumentation performance, trial product design, and implant dissociations.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
The Acumed Slide-Loc Anatomic Radial Head System is intended for use by surgeons with orthopedic training. The device is to be implanted by the surgeon in a sterile operating room setting. Implants are provided in sterile packages. The Acumed Anatomic Radial Head Slide-Loc System consists of modular heads and stems with accessories for anatomical replacement of the proximal portion of the radius and restore the natural articulation of the radial head with the radial notch of the ulna and capitellum of the distal humerus. The modular heads and stems are single use implantable devices. Each Acumed Slide-Loc Anatomic Radial Head System Set consists of 76 parts/instruments.
13076 parts total (8373 units of parts/instruments and 4703 units of implantable parts), in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Each Acumed Slide-Loc Anatomic Radial Head System Set consists of 76 parts/instruments. Below are Part numbers/ Description per set: 5001-0106N-S ARH Slide-Loc Standard Stem 6mm 5001-0107N-S ARH Slide-Loc Standard Stem 7mm 5001-0108N-S ARH…
Every code shown here, 1,996 characters
Each Acumed Slide-Loc Anatomic Radial Head System Set consists of 76 parts/instruments. Below are Part numbers/ Description per set: 5001-0106N-S ARH Slide-Loc Standard Stem 6mm 5001-0107N-S ARH Slide-Loc Standard Stem 7mm 5001-0108N-S ARH Slide-Loc Standard Stem 8mm 5001-0109N-S ARH Slide-Loc Standard Stem 9mm 5001-0110N-S ARH Slide-Loc Standard Stem 10mm 5001-0111N-S ARH Slide-Loc Standard Stem 11mm 5001-0112N-S ARH Slide-Loc Standard Stem 12mm 5001-0218L-S ARH Slide-Loc Head 18mm, Left 5001-0218R-S ARH Slide-Loc Head 18mm, Right 5001-0220L-S ARH Slide-Loc Head 20mm, Left 5001-0220R-S ARH Slide-Loc Head 20mm, Right 5001-0222L-S ARH Slide-Loc Head 22mm, Left 5001-0222R-S ARH Slide-Loc Head 22mm, Right 5001-0224L-S ARH Slide-Loc Head 24mm, Left 5001-0224R-S ARH Slide-Loc Head 24mm, Right 5001-0226L-S ARH Slide-Loc Head 26mm, Left 5001-0226R-S ARH Slide-Loc Head 26mm, Right 5001-0228L-S ARH Slide-Loc Head 28mm, Left 5001-0228R-S ARH Slide-Loc Head 28mm, Right 5001-0301N-S ARH Slide-Loc Neck +1mm 5001-0303N-S ARH Slide-Loc Neck +3mm 5001-0305N-S ARH Slide-Loc Neck +5mm 5001-0406L-S ARH Slide-Loc Long Stem 6mm, Left 5001-0406R-S ARH Slide-Loc Long Stem 6mm, Right 5001-0408L-S ARH Slide-Loc Long Stem 8mm, Left 5001-0408R-S ARH Slide-Loc Long Stem 8mm, Right 5001-0410L-S ARH Slide-Loc Long Stem 10mm, Left 5001-0410R-S ARH Slide-Loc Long Stem 10mm, Right 5001-0412L-S ARH Slide-Loc Long Stem 12mm, Left 5001-0412R-S ARH Slide-Loc Long Stem 12mm, Right 5101-0106N ARH Slide-Loc Trial Standard Stem 6mm 5101-0107N ARH Slide-Loc Trial Standard Stem 7mm 5101-0108N ARH Slide-Loc Trial Standard Stem 8mm 5101-0109N ARH Slide-Loc Trial Standard Stem 9mm 5101-0110N ARH Slide-Loc Trial Standard Stem 10mm 5101-0111N ARH Slide-Loc Trial Standard Stem 11mm 5101-0218L ARH Slide-Loc Trial Head 18mm, Left 5101-0218R ARH Slide-Loc Trial Head 18mm, Right 5101-0220L ARH Slide-Loc Trial Head 20mm, Left 5101-0220R ARH Slide-Loc Trial Head 20mm, Right 5101-0222L ARH Slide-Loc Trial Head 22mm,…
FDA’s list runs to 7,694 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.
US Nationwide distribution in the states of AK, AZ, CA, CO, CT, FL, HI, ID, IL, IN, KS, KY, LA, MA, MI, MN, MO, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, TN, TX, UT, VA, and WA and in Puerto Rico.
The states and territories these words name
35 states and territories.
Every one of them
- Alaska
- Arizona
- California
- Colorado
- Connecticut
- Florida
- Hawaii
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Michigan
- Minnesota
- Missouri
- Montana
- North Carolina
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Puerto Rico
- Tennessee
- Texas
- Utah
- Virginia
- Washington
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.
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 Apr 20, 2017.
- FDA classified it on May 31, 2017.
- FDA’s Enforcement Report published it on Jun 7, 2017.
- FDA terminated it on Dec 1, 2017.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Acumed LLC, of Hillsboro, OR.
- 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 7,694 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.