Reported Nov 18, 2020 · Terminated
Stryker Zyphr Disposable Cranial Perforator, Large 14/11 mm- is a sterile, single use cutting accessory intended for…
Stryker Instruments Div. of Stryker Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Stryker Instruments Div. of Stryker Corporation · 4100 E Milham Ave · Portage, MI · 49002-9704
Is this the product you have?
- 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 Number5100-060-001
- Lot codes and dates
- GTIN04546540716224
- Lot Numbers
240 of 240 codes
200290272003007720030087200310172003102720034017200350172003502720035037200360172003602720038017200380272004002720041017200420172004401720044027200470172004801720048027200480372005101720052017200520472005501720055027200550372005504720056017200570172005703720058017200580272005901720059027200590372005904720062017200620272006203720062047200630172006302720064017200660172006602720066037200660472006901720069027200710172007102720072017200790172007902720080017200830172008302720084017
- Expanded Recall 1/5/2120220067 20220077 20227027
- Amount recalled
- 18,492 devices. Expanded Recall total: 18,594 devices
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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