Severity
Moderate
FDA Devices recall · Reported May 17, 2017
mislabeled as 8mm tube but it is actually 9 mm in size. A 9mm subcomponent was erroneously substituted and etched as 8mm for the actual 8mm subcomponent part.
Zimmer Biomet, Inc. recalled Bone Dowell Harvest Tubes - a moderate-severity action.
Bone Dowell Harvest Tubes was recalled by Zimmer Biomet, Inc. in May 17, 2017. Reason: mislabeled as 8mm tube but it is actually 9 mm in size. A 9mm subcomponent was erroneously substituted and e…. Check the official notice for the remedy. Verify recall #Z-2059-2017 with the FDA Devices before acting.
The recall
Zimmer Biomet, Inc. issued this moderate-severity FDA Devices recall-mislabeled as 8mm tube but it is actually 9 mm in size. A 9mm subcomponent was erroneously substituted and e….
Sourced from official FDA Devices enforcement records. Verify recall #Z-2059-2017 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
This FDA Devices action (record #Z-2059-2017) was formally reported on May 17, 2017, with the manufacturer initiating the action on April 12, 2017. It is classified under Moderate severity (Class II), with a current status of Terminated. Zimmer Biomet, Inc. is listed as the recalling firm, operating out of Warsaw, IN. Federal records list the affected scope as 49.
The documented reason for this recall is: mislabeled as 8mm tube but it is actually 9 mm in size. A 9mm subcomponent was erroneously substituted and etched as 8mm for the actual 8mm subcomponent part. Distribution data in the federal record shows the product reached: No US distribution. JAPAN NETHERLANDS SINGAPORE SWITZERLAND. 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, 3 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 - 40,322 medical devices recalls on record
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.
Severity
Moderate
Affected scope
49
Related Recalls
6
3 from same agency
Bone Dowell Harvest Tubes
mislabeled as 8mm tube but it is actually 9 mm in size. A 9mm subcomponent was erroneously substituted and etched as 8mm for the actual 8mm subcomponent part.
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-2059-2017 |
| Date reported | May 17, 2017 |
| Date initiated | April 12, 2017 |
| Recalling firm | Zimmer Biomet, Inc. |
| Firm location | Warsaw, IN |
| Affected scope | 49 |
| Distribution | No US distribution. JAPAN NETHERLANDS SINGAPORE SWITZERLAND |
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.
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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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported May 17, 2017. 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.