Food, drugs, devices › Stryker Instruments Div. of Stryker Corporation
Device recall: Stryker Zyphr Disposable Cranial Perforator, Large 14/11 mm- is a sterile, single use cutting accessory intended for cut
Stryker Instruments Div. of Stryker Corporation (Portage, MI) initiated this device recall on 16 Oct 2020; FDA lists 1 product record under event 86670, classified Class II.
FDA defines Class II as 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. 93% of the 916 device enforcement events initiated in 2020 carry the same class.
Status: Terminated, terminated 22 Jun 2022. Initiation: voluntary: firm initiated. Stryker Instruments Div. of Stryker Corporation has 55 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Stryker Instruments Div. of Stryker Corporation, Portage, MI.
Reason for recall
"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."
Distribution
"Nationwide Foreign: Australia Brazil Canada Chile Colombia Hong Kong Italy Mexico Netherlands Netherlands New Zealand South Africa South Korea Spain Sweden Switzerland United Kingdom"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0431-2021 | 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 | Class II | Terminated | 18 Nov 2020 |
Context
Other enforcement events for Stryker Instruments Div. of Stryker Corporation
All 55 events for Stryker Instruments Div. of Stryker Corporation
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "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."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. 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.
Where was the product distributed?
FDA's distribution pattern field reads: "Nationwide Foreign: Australia Brazil Canada Chile Colombia Hong Kong Italy Mexico Netherlands Netherlands New Zealand South Africa South Korea Spain Sweden Switzerland United Kingdom"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 22 Jun 2022. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.