Severity
Moderate
FDA Devices recall · Reported April 15, 2020
Mislabeled: Actual blade width is 19 mm but the label indicates a width of 25 mm.
The recall
Synvasive Technology Inc issued this moderate-severity FDA Devices recall — Mislabeled: Actual blade width is 19 mm but the label indicates a width of 25 mm..
Sourced from official FDA Devices enforcement records. Verify recall #Z-1676-2020 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
This FDA Devices action (record #Z-1676-2020) was formally reported on April 15, 2020, with the manufacturer initiating the action on July 27, 2018. It is classified under Moderate severity (Class II), with a current status of Terminated. Synvasive Technology Inc is listed as the recalling firm, operating out of El Dorado Hills, CA. Federal records list the affected scope as 266 units.
The documented reason for this recall is: Mislabeled: Actual blade width is 19 mm but the label indicates a width of 25 mm. Distribution data in the federal record shows the product reached: US distribution to states of AL and NY. 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, 6 from FDA Devices — 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.
Where this recall sits in its category — 40,409 medical devices recalls on record
Of 100,165 recalls in the database, 23,668 are high severity, 72,097 moderate, and 4,400 low. This recall is classified moderate severity.
Severity
Moderate
Affected scope
266 units
Related Recalls
6
6 from same agency
ZIMMER Oscillating Saw Blade -Cutting 75mm x 19mm x 1.00/1.27mm.intended for bone or cartilage in orthopedic procedures. Manufactured By: Synvasive Technology, Inc., a Subsidiary of Zimmer
Mislabeled: Actual blade width is 19 mm but the label indicates a width of 25 mm.
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1676-2020 |
| Date reported | April 15, 2020 |
| Date initiated | July 27, 2018 |
| Recalling firm | Synvasive Technology Inc |
| Firm location | El Dorado Hills, CA |
| Affected scope | 266 units |
| Distribution | US distribution to states of AL and NY |
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
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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.
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Source: FDA, CPSC, and NHTSA federal recall databases. This recall: FDA Devices, reported April 15, 2020.
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 June 2026.