Stryker Zyphr Disposable Cranial Perforator, Large 14/11 mm- is a sterile, single use cutting accessory…
Medical device recall Z-0431-2021. Published in FDA’s Enforcement Report on Nov 18, 2020.
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 Nov 18, 2020. 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
- 18,492 devices. Expanded Recall total: 18,594 devices 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?
Potential for the inner bit to contain a crack, that may or may not be visible, which may lead to metal fragments entering the surgical site and/or delayed disengagment during use.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Stryker Zyphr Disposable Cranial Perforator, Large 14/11 mm- is a sterile, single use cutting accessory intended for cutting an 11 mm diameter access hole through the cranium of adult patients. Catalog Number: 5100-060-001
18,492 devices. Expanded Recall total: 18,594 devices, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
GTIN: 04546540716224 Lot Numbers: 20029027 20030077 20030087 20031017 20031027 20034017 20035017 20035027 20035037 20036017 20036027 20038017 20038027 20040027 20041017 20042017 20044017 20044027 20047017 20048017 20048027 20048037…
Every code shown here, 1,996 characters
GTIN: 04546540716224 Lot Numbers: 20029027 20030077 20030087 20031017 20031027 20034017 20035017 20035027 20035037 20036017 20036027 20038017 20038027 20040027 20041017 20042017 20044017 20044027 20047017 20048017 20048027 20048037 20051017 20052017 20052047 20055017 20055027 20055037 20055047 20056017 20057017 20057037 20058017 20058027 20059017 20059027 20059037 20059047 20062017 20062027 20062037 20062047 20063017 20063027 20064017 20066017 20066027 20066037 20066047 20069017 20069027 20071017 20071027 20072017 20079017 20079027 20080017 20083017 20083027 20084017 20084027 20084037 20084047 20084057 20094017 20094027 20094037 20094047 20099017 20099027 20099037 20101017 20101027 20101037 20101047 20101057 20101067 20101077 20106027 20106047 20106087 20106107 20106117 20106127 20106137 20107017 20107027 20107037 20107047 20107057 20108017 20108027 20108037 20108047 20108057 20108067 20111017 20111027 20111037 20112017 20112027 20112037 20112047 20113017 20113027 20113037 20118017 20118037 20120017 20120027 20120037 20121017 20121027 20122017 20122027 20122037 20122047 20125017 20127027 20127037 20127047 20128017 20128027 20128037 20128047 20128057 20129017 20131017 20131027 20131037 20134017 20134027 20136017 20136027 20136037 20136047 20136057 20136067 20136077 20139017 20139027 20139037 20141017 20141027 20141037 20141047 20142017 20142027 20142037 20142047 20143017 20143027 20146017 20146027 20147017 20147027 20147037 20147047 20148017 20148027 20148037 20150017 20150027 20150037 20150047 20154017 20154027 20155017 20155027 20155037 20156017 20157017 20157027 20157037 20161017 20162017 20162027 20164017 20167017 20167027 20168017 20168027 20168037 20171017 20171027 20171037 20171047 20171057 20171067 20171077 20171107 20177017 20177027 20177037 20178017 20178027 20178037 20189017 20189027 20189037 20189047 20189057 20189067 20190017 20190027 20192017 20195037 20197017 20199027 20199037 20199047 20199057 20199067 20202017 20202027 20203017 20203027 20203037…
FDA’s list runs to 2,244 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.
Nationwide Foreign: Australia Brazil Canada Chile Colombia Hong Kong Italy Mexico Netherlands Netherlands New Zealand South Africa South Korea Spain Sweden Switzerland United Kingdom
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.
The words say it went outside the United States too.
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 Oct 16, 2020.
- FDA classified it on Nov 6, 2020.
- FDA’s Enforcement Report published it on Nov 18, 2020.
- FDA terminated it on Jun 22, 2022.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Stryker Instruments Div. of Stryker Corporation, of Portage, MI.
- 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 2,244 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.