Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported November 18, 2020
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
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.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Stryker Instruments Div. of Stryker Corporation recalled Stryker Zyphr Disposable Cranial Perforator, Large 14/11 mm- is a sterile, single use cut… - a moderate-severity action.
Stryker Zyphr Disposable Cranial Perforator, Large 14/11 mm- is a sterile, single use cut… was recalled by Stryker Instruments Div. of Stryker Corporation in November 18, 2020. Reason: Potential for the inner bit to contain a crack, that may or may not be visible, which may lead to metal fragm…. Check the official notice for the remedy. Verify recall #Z-0431-2021 with the FDA Devices before acting.
The recall
Stryker Instruments Div. of Stryker Corporation issued this moderate-severity FDA Devices recall-Potential for the inner bit to contain a crack, that may or may not be visible, which may lead to metal fragm….
- Moderate
- severity level
- 18K units
- affected scope
- Class II
- classification
- November 18, 2020
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0431-2021 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0431-2021) was formally reported on November 18, 2020, with the manufacturer initiating the action on October 16, 2020. It is classified under Moderate severity (Class II), with a current status of Terminated. Stryker Instruments Div. of Stryker Corporation is listed as the recalling firm, operating out of Portage, MI. Federal records list the affected scope as 18,492 devices. Expanded Recall total: 18,594 devices.
The documented reason for this recall is: 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 data in the federal record shows the product reached: Nationwide Foreign: Australia Brazil Canada Chile Colombia Hong Kong Italy Mexico Netherlands Netherlands New Zealand South Africa South Korea Spain Sweden Switzerland United Kingdom. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,422 medical devices recalls on record
Where this recall sits in the database
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
18,492 devices. Expanded Recall total: 18,594 devices
Related Recalls
6
0 from same agency
Product description
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
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0431-2021 |
| Date reported | November 18, 2020 |
| Date initiated | October 16, 2020 |
| Recalling firm | Stryker Instruments Div. of Stryker Corporation |
| Firm location | Portage, MI |
| Affected scope | 18,492 devices. Expanded Recall total: 18,594 devices |
| 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 |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0431-2021) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was 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. Recalled by Stryker Instruments Div. of Stryker Corporation. Units affected: 18,492 devices. Expanded Recall total: 18,594 devices.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 18, 2020. Severity: Moderate. Recall number: Z-0431-2021.
Where was the recalled product distributed? ▼
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.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0431-2021) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Data Sources
Source: FDA, CPSC, and NHTSA federal recall databases. This recall: FDA Devices, reported November 18, 2020.
- Source: FDA - Food and Drug Administration, openFDA Enforcement API (food, drug, and medical device recalls)
- Source: CPSC - Consumer Product Safety Commission Recalls API (consumer product recalls and hazards)
- Source: NHTSA - National Highway Traffic Safety Administration Recalls API (vehicle safety recalls)
Recall information is sourced from official federal agency databases. Always verify recall details with the issuing agency for the most current status. This information is for research and awareness purposes only.
Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.