Product 32 consists of all product under
Medical device recall Z-1130-2016. 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
- 4018 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 32 consists of all product under product code: HWC and same usage: Item no: 47115401200 HERBERT BONE SCREW, 3.0MM 47115401400 HERBERT BONE SCREW, 3.0MM 47115401600 HERBERT BONE SCREW, 3.0MM 47115401800 HERBERT BONE SCREW, 3.0MM 47115402000 HERBERT BONE SCREW, 3.0MM 47115402200 HERBERT BONE SCREW, 3.0MM 47115402400 HERBERT BONE SCREW, 3.0MM 47115402600 HERBERT BONE SCREW, 3.0MM 47115402800 HERBERT BONE SCREW, 3.0MM 47115403000 HERBERT BONE SCREW, 3.0MM 47115502505 HERBERT CANNULATED BONE S 47115503005 HERBERT CANNULATED BONE S 47115503505 HERBERT CANNULATED BONE S 47115504005 HERBERT CANNULATED BONE S 47115504007 HERBERT CANNULATED BONE S 47115504505 HERBERT CANNULATED BONE S 47115504507 HERBERT CANNULATED BONE S 47115505005 HERBERT CANNULATED BONE S 47115505007 HERBERT CANNULATED BONE S 47115505505 HERBERT CANNULATED BONE S 47115505507 HERBERT CANNULATED BONE S 47115506005 HERBERT CANNULATED BONE S 47115506007 HERBERT CANNULATED BONE S 47115506505 HERBERT CANNULATED BONE S 47115506507 HERBERT CANNULATED BONE S 47115507005 HERBERT CANNULATED BONE S 47115507007 HERBERT CANNULATED BONE S 47115507505 HERBERT CANNULATED BONE S 47115507507 HERBERT CANNULATED BONE S 47115508005 HERBERT CANNULATED BONE S 47115508007 HERBERT CANNULATED BONE S 47115508505 HERBERT CANNULATED BONE S 47115508507 HERBERT CANNULATED BONE S 47115509005 HERBERT CANNULATED BONE S 47115509007 HERBERT CANNULATED BONE S 47115509505 HERBERT CANNULATED BONE S 47115509507 HERBERT CANNULATED BONE S 47115510005 HERBERT CANNULATED BONE S 47115510007 HERBERT CANNULATED BONE S 115001000 HERBERT MINI BONE SCREW 2 115001200 HERBERT MINI BONE SCREW 2 115001400 HERBERT MINI BONE SCREW 2 115001600 HERBERT MINI BONE SCREW 2 115001800 HERBERT MINI BONE SCREW 2 115002000 HERBERT MINI BONE SCREW 2 115002200 HERBERT MINI BONE SCREW 2 115002400 HERBERT MINI BONE SCREW 2 115201200 HERBERT/WHIPPLE CANN BONE 115201400 HERBERT/WHIPPLE CANN BONE 115201600 HERBERT/WHIPPLE CANN BONE 115201800 HERBERT/WHIPPLE CANN BONE 115202000 HERBERT/WHIPPLE CANN BONE 115202200 HERBERT/WHIPPLE CANN BONE 115202400 HERBERT/WHIPPLE CANN BONE 115202600 HERBERT/WHIPPLE CANN BONE 115202800 HERBERT/WHIPPLE CANN BONE 115203000 HERBERT/WHIPPLE CANN BONE 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.
4018, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
lot no.: 61849585 61912445 61912446 61849586 61849587 61912447 61912448 61941352 61827182 61849582 62024187 62153287 61774747 61827165 61827167 61849584 61904625 61928623 62024188 62024188N 61827172 61827173 61865263 61865265 61904627…
Every code shown here, 1,994 characters
lot no.: 61849585 61912445 61912446 61849586 61849587 61912447 61912448 61941352 61827182 61849582 62024187 62153287 61774747 61827165 61827167 61849584 61904625 61928623 62024188 62024188N 61827172 61827173 61865263 61865265 61904627 61912468 62024189 62031681 62211067 62024189N 61827157 61870904 61904626 61928624 62024190 62145270 62160893 61811070 61827193 61870905 61944998 62024191 62031682 62145271 62153288 62180565 61827151 61840634 61928627 61928628 62031639 62145272 62160895 61870906 61900329 62031646 62180567 61789465 61811156 61840635 61895711 61895713 61895714 61912679 61912682 61912691 61912694 61912695 61912699 61644731 61785346 61855921 61906705 62161934 61660596 61799289 61865276 61906699 61960093 61960095 62017439 62072611 62129843 62180552 62180552N 61660597 61865277 61865278 61936609 61936613 61963653 61988334 62017440 62027372 62040734 62112691 62138496 62142211 62328120 61660601 61799283 61799285 61835773 61865279 61906706 61936621 61936623 61981198 61981199 61981201 62009804 62027373 62086218 62097341 62112695 62198887 62258967 62027374 62027374N 61799286 61835774 61887206 61906707 61978705 61978706 62008674 62065599 62086222 62112699 62187870 62328128 61988338 61612598 61660607 61788245 61843085 61865281 61906701 61968182 61968183 62008675 62086226 62097343 62187869 62198874 62258968 61988351 62180554 61819964 61880819 61968184 62017438 62086230 62138499 62223009 61914885 62069022 61612601 61887207 61968185 62053620 62112701 62198875 61955489 62027384 61968186 62040193 62161936 61887209 61946364 62005539 62129844 62198877 61685418 61988350 62085978 61865282 61988337 62027385 62097346 61923065 62065601 61887210 61978707 62005540 62072612 61946365 62072613 61887212 61960099 61963652 62072614 62198878 62204637 62097339 61887213 61978710 62053628 62161940 61799296 62005538 61923068 62053629 62138505 62204640 62304903 62304903N 62008676 61788253 62017441 61774750 61906704 61923071 62129845 62161957 62328136 61840636 62069021 62180559 61840639…
FDA’s list runs to 4,066 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 4,066 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.