Product 37 consists of all product under
Medical device recall Z-1135-2016. 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
- 1777 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 37 consists of all product under product code: HSB and same usage: Item no: 225302055 INTERLOCKING IM SCREW LG 225303055 INTERLOCKING IM SCREW LG 225304055 INTERLOCKING IM SCREW LG 225304555 INTERLOCKING IM SCREW LG 225305055 INTERLOCKING IM SCREW LG 225305555 INTERLOCKING IM SCREW LG 225306055 INTERLOCKING IM SCREW LG 225306555 INTERLOCKING IM SCREW LG 225307055 INTERLOCKING IM SCREW LG 225307555 INTERLOCKING IM SCREW LG 225308055 INTERLOCKING IM SCREW LG 225308555 INTERLOCKING IM SCREW LG 225309055 INTERLOCKING IM SCREW LG 225302542 INTERLOCKING IM SCREW MED 225303042 INTERLOCKING IM SCREW MED 225303542 INTERLOCKING IM SCREW MED 225304042 INTERLOCKING IM SCREW MED 225304542 INTERLOCKING IM SCREW MED 225305042 INTERLOCKING IM SCREW MED 225305542 INTERLOCKING IM SCREW MED 225306042 INTERLOCKING IM SCREW MED 225306542 INTERLOCKING IM SCREW MED 225307042 INTERLOCKING IM SCREW MED 225307542 INTERLOCKING IM SCREW MED 225308042 INTERLOCKING IM SCREW MED 225308542 INTERLOCKING IM SCREW MED 225302037 INTERLOCKING IM SCREW SML 225302537 INTERLOCKING IM SCREW SML 225303037 INTERLOCKING IM SCREW SML 225303537 INTERLOCKING IM SCREW SML 225304037 INTERLOCKING IM SCREW SML 225304537 INTERLOCKING IM SCREW SML 225305037 INTERLOCKING IM SCREW SML 225305537 INTERLOCKING IM SCREW SML 225306037 INTERLOCKING IM SCREW SML 225306537 INTERLOCKING IM SCREW SML 225308537 INTERLOCKING IM SCREW SML Product Usage: An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.
1777, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
lot no.: 61906265 61764344 61764345 61763538 61804376 61804377 61804378 61809821 61843699 61889644 61912613 61920742 61934239 61934254 61934264 61934275 61968078 61983673 62005552 62021122 62038732 62165487 62165488 62188649 62188650…
Every code shown here, 1,998 characters
lot no.: 61906265 61764344 61764345 61763538 61804376 61804377 61804378 61809821 61843699 61889644 61912613 61920742 61934239 61934254 61934264 61934275 61968078 61983673 62005552 62021122 62038732 62165487 62165488 62188649 62188650 62253382 62253386 61709145 61763552 61763553 61804388 61841501 61881343 61889662 61912626 61920743 61934285 61934286 61934287 61934288 61993619 62005554 62021123 62038746 62121122 62121123 62176083 62176084 62188636 62253396 62253398 62298584 61809822 61821684 61839142 61876353 61876354 61876355 61876356 61878893 61889664 61908098 61908099 61908101 61908103 61968079 61968080 61979092 62027386 62027387 62027388 62027389 62075773 62075774 62075775 62075776 62075781 62075782 62075785 62075786 62075792 62075803 62075804 62075805 62075806 62075807 62121136 62121139 62121141 62121146 62188652 62188654 62188655 62188658 62188659 62188661 62188662 62188663 62262078 61665049 61729658 61763551 61809823 61809824 61836999 61859423 61859425 61859426 61859427 61859428 61859429 61859430 61878766 61878780 61908104 61934289 61934290 61968081 61979095 61993623 62005555 62038756 62102479 62102480 62102481 62102482 62102483 62102484 62102485 62102486 62102502 62102504 62102518 62102520 62102521 62102522 62102523 62102524 62102525 62102526 62102528 62102529 62102530 62102531 62102532 62137923 62137924 62165524 62165525 62165526 62165528 62165529 62165531 62165532 62165533 62165534 61665051 61729660 61763513 61809826 61809827 61836991 61836992 61836993 61855506 61855507 61855508 61855519 61855521 61855524 61855528 61872543 61872544 61872545 61878784 61940664 61940667 61940670 61979097 61979099 62009852 62009853 62027390 62027391 62122328 62122329 62122330 62122331 62122332 62122333 62122334 62122335 62122337 62122340 62122573 62160813 62160815 62194667 62194668 62194670 62194671 62237301 62237304 62237306 62237308 62237311 62242582 62248997 62248998 62249001 62249002 61665053 61729665 61763517 61763518 61809828 61830467 61830468 61841505 61859453 61859455…
FDA’s list runs to 10,576 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 10,576 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.