Product 46 consists of all product under
Medical device recall Z-1144-2016. Published in FDA’s Enforcement Report on Mar 23, 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 Mar 23, 2016. 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
- 3190 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?
As a result of the insufficient sealer calibration data for product packaged in firm’s Building II between August 2010 and April 2013. The affected products are sterile.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Product 46 consists of all product under product code: HWC and same usage: Item no: 114204012 MINI MAGNA-FX CANN SCREW 114204016 MINI MAGNA-FX CANN SCREW 114204020 MINI MAGNA-FX CANN SCREW 114204024 MINI MAGNA-FX CANN SCREW 114204028 MINI MAGNA-FX CANN SCREW 114204032 MINI MAGNA-FX CANN SCREW 114204036 MINI MAGNA-FX CANN SCREW 114204040 MINI MAGNA-FX CANN SCREW 114204044 MINI MAGNA-FX CANN SCREW 114204048 MINI MAGNA-FX CANN SCREW 114204055 MINI MAGNA-FX CANN SCREW 114204065 MINI MAGNA-FX CANN SCREW 114204124 MINI MAGNA-FX CANN SCREW 114204126 MINI MAGNA-FX CANN SCREW 114204128 MINI MAGNA-FX CANN SCREW 114204130 MINI MAGNA-FX CANN SCREW 114204132 MINI MAGNA-FX CANN SCREW 114204134 MINI MAGNA-FX CANN SCREW 114204136 MINI MAGNA-FX CANN SCREW 114204138 MINI MAGNA-FX CANN SCREW 114204140 MINI MAGNA-FX CANN SCREW 114204142 MINI MAGNA-FX CANN SCREW 114204144 MINI MAGNA-FX CANN SCREW 114204146 MINI MAGNA-FX CANN SCREW 114204148 MINI MAGNA-FX CANN SCREW 114204150 MINI MAGNA-FX CANN SCREW 114204155 MINI MAGNA-FX CANN SCREW 114204160 MINI MAGNA-FX CANN SCREW 114204165 MINI MAGNA-FX CANN SCREW 114204170 MINI MAGNA-FX CANN SCREW 114205012 MINI MAGNA-FX CANN SCREW 114205016 MINI MAGNA-FX CANN SCREW 114205020 MINI MAGNA-FX CANN SCREW 114205024 MINI MAGNA-FX CANN SCREW 114205028 MINI MAGNA-FX CANN SCREW 114205032 MINI MAGNA-FX CANN SCREW 114205036 MINI MAGNA-FX CANN SCREW 114205040 MINI MAGNA-FX CANN SCREW 114205044 MINI MAGNA-FX CANN SCREW 114205048 MINI MAGNA-FX CANN SCREW 114205055 MINI MAGNA-FX CANN SCREW 114205065 MINI MAGNA-FX CANN SCREW 114205124 MINI MAGNA-FX CANN SCREW 114205126 MINI MAGNA-FX CANN SCREW 114205128 MINI MAGNA-FX CANN SCREW 114205130 MINI MAGNA-FX CANN SCREW 114205132 MINI MAGNA-FX CANN SCREW 114205134 MINI MAGNA-FX CANN SCREW 114205136 MINI MAGNA-FX CANN SCREW 114205138 MINI MAGNA-FX CANN SCREW 114205140 MINI MAGNA-FX CANN SCREW 114205142 MINI MAGNA-FX CANN SCREW 114205144 MINI MAGNA-FX CANN SCREW 114205146 MINI MAGNA-FX CANN SCREW 114205148 MINI MAGNA-FX CANN SCREW 114205150 MINI MAGNA-FX CANN SCREW 114205155 MINI MAGNA-FX CANN SCREW 114205160 MINI MAGNA-FX CANN SCREW 114205165 MINI MAGNA-FX CANN SCREW 114205170 MINI MAGNA-FX CANN SCREW Product Usage: A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.
3190, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
lot no.: 62083732 62278719 62278734 62346023 62351544 62346023N 62351544N 61885643 62239545 62239546 62239547 62239548 62290035 62290040 61890456 62005296 62223791 62299098 62346024 61910239 62178894 62346025 61930882 62157290 62248127…
Every code shown here, 1,995 characters
lot no.: 62083732 62278719 62278734 62346023 62351544 62346023N 62351544N 61885643 62239545 62239546 62239547 62239548 62290035 62290040 61890456 62005296 62223791 62299098 62346024 61910239 62178894 62346025 61930882 62157290 62248127 62326540 61759543 61892650 61958361 62178895 62346026 62346027 62346026N 62346027N 61627269 61740666 61870977 62079036 62110010 62178896 62234077 62234078 62234079 62234080 62234081 62234082 62234084 62340974 62340975 62340978 62340980 62340983 62344456 62344457 62344459 62344460 62340974N 62340975N 62340978N 62340980N 62340983N 62344456N 62344457N 62344459N 62344460N 61620146 61740667 61839169 61930883 62083735 62223795 62339582 62339585 62339586 62339588 62339589 62339590 62339585N 62339586N 62339588N 62339589N 62339590N 61664666 61759547 61885657 61930884 62083738 62248129 62334669 62334674 62334676 62334680 62337028 62337030 62346148 62351545 62334669N 62334674N 62334680N 62337030N 62346148N 62351545N 61755871 61842980 61950125 62110013 62332636 62336795 62337610 62340759 61719688 61740668 61764765 61889321 61930885 61958362 62110016 62197619 61842575 61885662 61910240 61958364 62005298 62131627 62248131 61664668 61740669 61809454 61870981 61870982 61942560 61952205 62074451 62109223 62168534 62168536 62193745 62281959 61835310 61835311 61870983 61930887 61958365 62031613 62118362 62168528 62168530 62193746 62193747 61839170 61862390 61930889 61940170 61956896 62005299 62074448 62107919 62144850 62144851 62193749 62223801 61740670 61798065 61839171 61862397 61862398 61892651 61930890 61942566 61951771 61999816 61999817 62079037 62110024 62168522 62168524 62197620 62197621 62239549 61620147 61788220 61788221 61840997 61885668 61885672 61950128 62031606 62106211 62144736 62144739 62144740 62197622 62197623 61809455 61836434 61840999 61841001 61870989 61870990 61870991 61910905 61930891 61942589 61952206 62005300 62005301 62079035 62112478 62144853 62144855 62144856 62178897 62200611 62239550 62281962 61752988 61798071 61839182…
FDA’s list runs to 4,856 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
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.
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 Jan 11, 2016.
- FDA classified it on Mar 12, 2016.
- FDA’s Enforcement Report published it on Mar 23, 2016.
- FDA terminated it on Apr 13, 2017.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Zimmer Manufacturing B.V., of Mercedita, PR.
- 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 4,856 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.