Severity
Moderate
FDA Devices recall · Reported February 19, 2020
Inner draw rod, which threads into the cage may potentially be separated from the proximal knob of the inserter
Medicrea International recalled Medicrea TLIF-B Holder, short intended for Intervertebral body fusion device Catalog: Nu… - a moderate-severity action.
Medicrea TLIF-B Holder, short intended for Intervertebral body fusion device Catalog: Nu… was recalled by Medicrea International in February 19, 2020. Reason: Inner draw rod, which threads into the cage may potentially be separated from the proximal knob of the insert…. Check the official notice for the remedy. Verify recall #Z-1156-2020 with the FDA Devices before acting.
The recall
Medicrea International issued this moderate-severity FDA Devices recall-Inner draw rod, which threads into the cage may potentially be separated from the proximal knob of the insert….
Sourced from official FDA Devices enforcement records. Verify recall #Z-1156-2020 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
This FDA Devices action (record #Z-1156-2020) was formally reported on February 19, 2020, with the manufacturer initiating the action on October 2, 2019. It is classified under Moderate severity (Class II), with a current status of Terminated. Medicrea International is listed as the recalling firm, operating out of Rillieux La Pape. Federal records list the affected scope as 14 units.
The documented reason for this recall is: Inner draw rod, which threads into the cage may potentially be separated from the proximal knob of the inserter Distribution data in the federal record shows the product reached: OH, VA. 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
14 units
Related Recalls
6
3 from same agency
Medicrea TLIF-B Holder, short intended for Intervertebral body fusion device Catalog: Number A24200010
Inner draw rod, which threads into the cage may potentially be separated from the proximal knob of the inserter
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1156-2020 |
| Date reported | February 19, 2020 |
| Date initiated | October 2, 2019 |
| Recalling firm | Medicrea International |
| Firm location | Rillieux La Pape |
| Affected scope | 14 units |
| Distribution | OH, VA |
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 February 19, 2020. 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.