Product 17 consists of all product under
Medical device recall Z-1115-2016. 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
- 87341 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 17 consists of all product under product code: LPH and same usage: Item no: 625004515 BONE SCREW 4.5X15 SELF-TA 625004520 BONE SCREW 4.5X20 SELF-TA 625004525 BONE SCREW 4.5X25 SELF-TA 625004530 BONE SCREW 4.5X30 SELF-TA 625004535 BONE SCREW 4.5X35 SELF-TA 625004540 BONE SCREW 4.5X40 SELF-TA 625004550 BONE SCREW 4.5X50 SELF-TA 625006515 BONE SCREW 6.5X15 SELF-TA 625006520 BONE SCREW 6.5X20 SELF-TA 625006525 BONE SCREW 6.5X25 SELF-TA 625006530 BONE SCREW 6.5X30 SELF-TA 625006535 BONE SCREW 6.5X35 SELF-TA 625006540 BONE SCREW 6.5X40 SELF-TA 625006550 BONE SCREW 6.5X50 SELF-TA 625006560 BONE SCREW 6.5X60 SELF-TA 625006570 BONE SCREW 6.5X70 SELF-TA Product Usage: For use in total or hemi hip arthroplasty
87341, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
lot no.: 61986559 61986661 62332485 62339373 62339372 61674407 61953445 62048819 62308513 62326387 62326389 62044206 62332484 62339371 61623552 61623554 61661363 61667818 61667821 61825066 61881292 61968207 61968208 61968209 61968210…
Every code shown here, 1,996 characters
lot no.: 61986559 61986661 62332485 62339373 62339372 61674407 61953445 62048819 62308513 62326387 62326389 62044206 62332484 62339371 61623552 61623554 61661363 61667818 61667821 61825066 61881292 61968207 61968208 61968209 61968210 61968212 61968213 61996180 61996181 62011506 62032192 62073694 62163394 62163395 62176480 62176481 62176482 62176484 62176485 62176490 62194287 62194288 62194295 62227248 62292597 62292598 62292599 62292600 62292601 62292602 62318725 62318726 62318818 62319085 62332482 62337854 62337855 62352228 62352230 62163394N 62319085N 61623693 61661367 61667833 61667834 61674415 61674417 61801347 61801351 61836013 61836017 61836018 61868984 61874772 61874773 61878940 61878943 61878944 61878945 61885304 61885305 61890085 61890088 61908410 61908411 61929734 61929741 61929742 61929743 61943261 61943264 61948726 61948727 61953452 61953456 61953457 61974150 61974152 61974156 61974158 61980039 61980040 61980044 61980045 61983076 61983077 61983078 61996185 62011509 62011510 62011511 62011512 62011513 62016785 62021129 62021130 62021131 62021136 62032195 62073698 62089906 62089907 62089908 62090517 62090524 62110368 62110369 62110370 62163402 62163405 62163409 62163414 62176499 62176508 62188030 62188031 62188034 62188035 62194296 62194297 62194301 62194302 62211380 62221233 62256198 62256201 62256202 62256203 62256204 62256206 62256207 62256208 62256209 62256210 62256211 62256212 62256213 62256214 62256215 62256216 62292603 62292604 62292605 62292606 62292607 62292608 62292609 62292610 62292611 62292612 62292613 62292614 62313348 62313349 62313350 62313351 62318720 62318721 62318812 62318813 62318814 62318815 62319087 62326321 62326322 62326323 62326324 62326563 62326564 62332479 62332480 62337844 62337845 62337847 62337848 62346362 62346376 62346377 62358307 62292607N 62292614N 62318814N 62326323N 62326563N 61636597 61674423 61674429 61801376 61836030 61836037 61878952 61881303 61881304 61881595 61881596 61881598 61881602 61881608 61881609 61881610…
FDA’s list runs to 8,715 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 8,715 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.