smith&nephew PROFIX Mallet, 750 GRAMS
Medical device recall Z-0696-2020. Published in FDA’s Enforcement Report on Dec 25, 2019.
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 Dec 25, 2019. 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
- 1371 devices 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?
There is a a potential failure mode associated with the use of the mallet, wherein the poly tip of the mallet may become loose and/or come off during use. If the potential failure mode occurs, particles generated in the poly thread potentially could enter the surgical field or a delay in surgery could occur if the tip disengages during the use of the mallet.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
smith&nephew PROFIX Mallet, 750 GRAMS, REF 71512452 - Product Usage: The PROFIX Mallet is a reusable surgical instrument used to tap instruments or implants during knee or hip surgery.
1371 devices, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Lot Numbers: 17AM17766 17AM17767 17CM01798 17CM01799 17CM01800 17CM01801 17CM01802 17CM01803 17CM01804 17CM01805 17CM01806 17CM01807 17CM02636 17CM02637 17CM02638 17CM02639 17CM02640 17CM02641 17CM02641A 17CM02642 17CM02643 17CM02644…
Every code shown here, 1,817 characters
Lot Numbers: 17AM17766 17AM17767 17CM01798 17CM01799 17CM01800 17CM01801 17CM01802 17CM01803 17CM01804 17CM01805 17CM01806 17CM01807 17CM02636 17CM02637 17CM02638 17CM02639 17CM02640 17CM02641 17CM02641A 17CM02642 17CM02643 17CM02644 17CM02645 17CM02646 17CM02647 17CM02648 17CM05047 17CM05048 17CM05049 17CM05050 17CM05050A 17CM05051 17CM05052 17CM05053 17CM05054 17CM05055 17CM05056 17CM05057 17CM05058 17CM05059 17CM07985 17CM07986 17CM07987 17CM07988 17CM10164 17CM10166 17CM10168 17CM15488 17CM15490 17CM15492 17CM15493 17CM15494 17CM15496 17CM15499 17CM19463 17CM19464 17CM19466 17CM19468 17CM19469 17CM19470 17CM19471 17CM19473 17DM03540 17DM03542 17DM03544 17DM03545 17DM03547 17DM03548 17DM03549 17DM03550 17DM03551 17DM03552 17DM03553 17DM10064 17DM10066 17DM10069 17DM10072 17DM14585 17DM14586 17DM14587 17DM14588 17DM14589 17DM14590 17EM00408 17EM00409 17EM00410 17EM00412 17EM00413 17EM00414 17EM00415 17EM00416 17EM00417 17EM00419 17EM00420 17EM00421 17EM00422 17EM00423 17EM00424 17EM05703 17EM05704 17EM05705 17EM05706 17EM05712 17EM10828 17EM10828A 17EM10829 17EM10830 17EM15105 17EM15106 17EM15107 17EM15108 17EM15109 17EM15110 17EM21229 17EM21230 17EM21233 17EM21236 17EM21238 17EM21239 17EM21242 17EM21245 17FM09954 17FM09955 17FM09956 17FM09957 17FM09958 17FM09959 17FM09959A 17GM07654 17GM07655 17GM07656 17GM07657 17GM07658 17GM07659 17GM07660 17GM07661 17GM07662 17GM07663 17GM07664 17GM07665 17GM07677 17GM07678 17GM07679 17GM07680 17GM07681 17GM07682 17GM07683 17GM07684 17GM07685 17GM07686 17GM07687 17GM07688 17GM10245 17GM12933 17GM12934 17GM12935 17GM15687 17GM15688 17GM15689 17GM15690 17JM01118 17JM04860P 17JM09449 17JM10724 17JM11956 17JM11957 17KM04646 17KM08204 17KM08207 17LM10125 17LM11933 17LM14786 17LM15874 17LM15875 17MM05227 17MM05228 17MM10461 18KK00010 18KK00070 18LK00128
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 distribution and countries of Belgium, Canada, China, Columbia, Costa Rica, Finland, France, Germany, Great Britain, Hong Kong, Italy, Netherlands, Norway, Panama, Poland, Switzerland, United Arab Emirates, Venezuela.
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 Nov 11, 2019.
- FDA classified it on Dec 17, 2019.
- FDA’s Enforcement Report published it on Dec 25, 2019.
- FDA terminated it on May 7, 2021.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Smith & Nephew, Inc., of Memphis, TN.
- 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.”
- 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.