Product 2 consists of all products
Medical device recall Z-1100-2016. 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
- 35,032 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 2 consists of all products product code LPH, and same usage: 801802202 12/14 COCR FEMORAL HEAD 2 801802220 12/14 COCR FEMORAL HEAD 2 801802230 12/14 COCR FEMORAL HEAD 2 801802601 12/14 COCR FEMORAL HEAD 2 801802602 12/14 COCR FEMORAL HEAD 2 801802603 12/14 COCR FEMORAL HEAD 2 801802604 12/14 COCR FEMORAL HEAD 2 801802605 12/14 COCR FEMORAL HEAD 2 801802801 12/14 COCR FEMORAL HEAD 2 801802802 12/14 COCR FEMORAL HEAD 2 801802803 12/14 COCR FEMORAL HEAD 2 801802805 12/14 COCR FEMORAL HEAD 2 801802814 12/14 COCR FEMORAL HEAD 2 801803201 12/14 COCR FEMORAL HEAD 3 801803202 12/14 COCR FEMORAL HEAD 3 801803203 12/14 COCR FEMORAL HEAD 3 801803205 12/14 COCR FEMORAL HEAD 3 801803214 12/14 COCR FEMORAL HEAD 3 801803601 12/14 COCR FEMORAL HEAD 3 801803602 12/14 COCR FEMORAL HEAD 3 801803603 12/14 COCR FEMORAL HEAD 3 801803604 12/14 COCR FEMORAL HEAD 3 801803605 12/14 COCR FEMORAL HEAD 3 801804001 12/14 COCR FEMORAL HEAD 4 801804002 12/14 COCR FEMORAL HEAD 4 801804003 12/14 COCR FEMORAL HEAD 4 801804004 12/14 COCR FEMORAL HEAD 4 902602100 6 DEGREE COCR FEM HEAD 22 32902603935 FEM HD 26MMDIA SHT NK+ 32902603800 FEMORAL HEAD +0.5 X 22 MM 32902604810 FEMORAL HEAD +3.5 X 22 MM 32902604845 FEMORAL HEAD +7.0 X 22 MM For use in total or hemi hip arthroplasty
35,032, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
lot no. 61982251 61982253 62192505 62235729 62235730 62240303 62240304 62240305 62256057 62262795 62262796 62266503 62266504 62268529 62268530 62268533 62291950 62291952 62291954 62291955 62291956 62309178 62309180 62309182 62309184…
Every code shown here, 1,992 characters
lot no. 61982251 61982253 62192505 62235729 62235730 62240303 62240304 62240305 62256057 62262795 62262796 62266503 62266504 62268529 62268530 62268533 62291950 62291952 62291954 62291955 62291956 62309178 62309180 62309182 62309184 62340128 62340129 62340130 62343407 62360082 62360083 62360103 62383105 62383106 62383107 62384211 62384212 61674847 62192500 62235731 62240306 62256051 62256052 62268531 62291959 62291960 62314454 62314455 62340132 62383102 62383103 62383104 62400488 61659979 61674849 62005410 62054842 62192496 62192498 62240307 62256054 62256055 62268532 62291957 62291958 62309177 62314456 62340133 62384213 62395856 62395857 62395858 62400490 61664630 62203617 62384215 62268528 62384214 61634943 62203620 62384216 62400542 62203620N 62384217 62400492 61670802 61683632 00370435N 61683632N 61660161 61670806 61670808 61670810 61683637 61817543 61817544 61817545 61820842 61873739 61882583 61882584 61884402 61926418 61926420 61926422 61945113 61983739 61983740 61983741 62093440 62115045 62115050 62144980 62144983 62151885 62188342 62200268 62210455 62210457 62210459 62212011 62221030 62221031 62221032 62221033 62221881 62221882 62222774 62222776 62222777 62234498 62234499 62234501 62234502 62252069 62256034 62256036 62256037 62256038 62256039 62258947 62258952 62266506 62266507 62266508 62267509 62267511 62273054 62273055 62273056 62273057 62276474 62279263 62279264 62279265 62279266 62279267 62279268 62282935 62282936 62293212 62293213 62309170 62309171 62309172 62309173 62309175 62309176 62311651 62311652 62311653 62315596 62315598 62315599 62315602 62315604 62322474 62322475 62322476 62326135 62326136 62326137 62326138 62326139 62330780 62330781 62330782 62332058 62332059 62332061 62332062 62332064 62332078 62346603 62346604 62346605 62358925 62358926 62358927 62358928 62358929 62358930 62362992 62362993 62381575 62381576 62381577 62381578 62381579 62381580 62383115 62384230 62401276 62406697 62406698 62406699 62406701 62326138N 61589212 61600758…
FDA’s list runs to 12,303 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 12,303 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
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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.