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Terminated

Medicrea TLIF-B Holder, short intended for Intervertebral body fusion device Catalog: Number A24200010

FDA Recall Z-1156-2020 · Posted None

Recalling FirmMedicrea International
Recall StatusTerminated
Product CodeMAX
Date Initiated2019-10-02
Date Terminated2021-02-08
Product Quantity14 units

Reason for Recall

Inner draw rod, which threads into the cage may potentially be separated from the proximal knob of the inserter

Firm Action

Medicrea Issued Voluntary Product Recall dated 10/3/19 stating reason for recall, health risk and action to take: 1. Immediately check your internal inventory and quarantine all subject devices pending return to MEDICREA USA 2. Circulate this notification internally to all interested/affected parties. 3. Inform MEDICREA USA if any of the subject devices have been distributed to other organizations. 4. Please inform M EDICREA of any adverse events concerning the use of the subject devices. Complete the attached customer response form. Contact person for this action is given below: Tim Huntington MEDICREA USA QA Manager Tel : 646-490-2426 Mail : [email protected]

Root Cause

Process control

Distribution Pattern

OH, VA

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K163595IMPIX 3D Print CagesMedicrea International SA · 2017-11-13

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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