TLC¿ Self Retaining Retractor System Contents 1-RETRACTOR FRAME 6-ELASTIC STAYS STERILE EO
Medical device recall Z-0684-2016. Published in FDA’s Enforcement Report on Jan 27, 2016.
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 Jan 27, 2016. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word, and 25 states named
- 2,570 units 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 was notified by some of their customers that some of the sealed pouches contain tears compromising the sterility of the product.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
TLC¿ Self Retaining Retractor System Contents 1-RETRACTOR FRAME 6-ELASTIC STAYS STERILE EO Rx ONLY. Indicated for use in the retraction of soft tissue away from the operative surface.
2,570 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Part Number M0068201750: Lot # 14112171 Exp Date 2017/11, Lot # 14112177 Exp Date 2017/11, Lot # 14120576 Exp Date 2017/05, Lot # 14120579 Exp Date 2017/11, Lot # 14121661 Exp Date 2017/12, Lot # 14121862 Exp Date 2017/12, Lot # 14121863…
Every code shown here, 1,996 characters
Part Number M0068201750: Lot # 14112171 Exp Date 2017/11, Lot # 14112177 Exp Date 2017/11, Lot # 14120576 Exp Date 2017/05, Lot # 14120579 Exp Date 2017/11, Lot # 14121661 Exp Date 2017/12, Lot # 14121862 Exp Date 2017/12, Lot # 14121863 Exp Date 2017/12, Lot # 15010199 Exp Date 2017/12, Lot # 15010200 Exp Date 2017/12, Lot # 15011528 Exp Date 2018/01, Lot # 15011529 Exp Date 2018/01, Lot # 15011530 Exp Date 2018/01, Lot # 15011531 Exp Date 2018/01, Lot # 15012638 Exp Date 2017/12, Lot # 15012640 Exp Date 2017/11, Lot # 15013724 Exp Date 2017/11, Lot # 15013788 Exp Date 2018/01, Lot # 15013789 Exp Date 2018/01, Lot # 15013790 Exp Date 2018/01, Lot # 15013791 Exp Date 2018/01, Lot # 15020046 Exp Date 2018/01, Lot # 15020047 Exp Date 2017/12, Lot # 15020048 Exp Date 2018/01, Lot # 15021047 Exp Date 2018/01, Lot # 15021049 Exp Date 2018/01, Lot # 15021472 Exp Date 2018/02, Lot # 15021473 Exp Date 2018/02, Lot # 15021474 Exp Date 2018/02, Lot # 15024336 Exp Date 2018/01, Lot # 15030309 Exp Date 2018/01, Lot # 15030310 Exp Date 2017/11, Lot # 15030317 Exp Date 2018/01, Lot # 15032508 Exp Date 2018/03, Lot # 15034955 Exp Date 2018/03, Lot # 15035013 Exp Date 2018/03, Lot # 15040424 Exp Date 2018/02, Lot # 15040425 Exp Date 2018/01, Lot # 15040426 Exp Date 2018/01, Lot # 15040681 Exp Date 2018/04, Lot # 15040682 Exp Date 2018/04, Lot # 15041220 Exp Date 2018/04, Lot # 15050026 Exp Date 2018/01, Lot # 15050027 Exp Date 2018/03, Lot # 15050029 Exp Date 2018/03, Lot # 15061724 Exp Date 2018/04, Lot # 15061725 Exp Date 2018/04, Lot # 15082274 Exp Date 2018/04, Lot # 15082325 Exp Date 2018/04, Lot # 15082326 Exp Date 2018/05, Lot # 15082837 Exp Date 2018/08, Lot # 15082838 Exp Date 2018/08, Lot # 15082839 Exp Date 2018/08, Lot # 15084674 Exp Date 2018/08, Lot # 15084675 Exp Date 2018/08, Lot # 15084676 Exp Date 2018/08, Lot # 15084745 Exp Date 2018/08, Lot # 15084945 Exp Date 2018/08, Lot # 15084946 Exp Date 2018/08, Lot # 15090470 Exp Date 2018/08, Lot # 15090472 Exp Date…
FDA’s list runs to 3,747 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.
Worldwide Distribution-US (nationwide) including the states of AL, AR, AZ, CA, CT,FL, GA, IA, IN, KS, KY, MA, MD, MI, MN, NC, NH, NJ, OH, SC, TN, TX, UT, VA & WI., and the countries of Austria, Germany, Italy, Japan, Spain, Sweden & Switzerland.
The states and territories these words name
25 states and territories.
Every one of them
- Alabama
- Arkansas
- Arizona
- California
- Connecticut
- Florida
- Georgia
- Iowa
- Indiana
- Kansas
- Kentucky
- Massachusetts
- Maryland
- Michigan
- Minnesota
- North Carolina
- New Hampshire
- New Jersey
- Ohio
- South Carolina
- Tennessee
- Texas
- Utah
- Virginia
- Wisconsin
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 Nov 25, 2015.
- FDA classified it on Jan 21, 2016.
- FDA’s Enforcement Report published it on Jan 27, 2016.
- FDA terminated it on Oct 27, 2016.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Abeon Medical Corporation, of Brecksville, OH.
- 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 3,747 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
-
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.