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Terminated

Medicrea International Universal Counter Torque for use with the Pass TULIP [Spinal] System Ref : A22020500

FDA Recall Z-1234-2020 · Posted None

Recalling FirmMedicrea International
Recall StatusTerminated
Product CodeNKB
Date Initiated2019-11-11
Date Terminated2020-10-14
Product Quantity3 units

Reason for Recall

Incompatible universal counter torque (A22020500) with the nut driver T30 (A22020220)

Firm Action

Medicrea issued notification dated 11/11/19 via email, 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. 2. Circulate this Field Safety Notice internally to all interested/affected parties. 3. Inform MEDICREA if any of the subject devices have been distributed to other organizations. inform MEDICREA 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: Karine TROGNEUX-MEDICREA INTERNATIONAL Regulatory Affairs Manager Direct : +33(0)4.69.85.95.39 Standard : +33 (0)4.72.01.87.87. Fax - N +33 (0)04 72 01 87 88 Mail : [email protected]

Root Cause

Device Design

Distribution Pattern

CA, FL

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K190376PASS LP Spinal SystemMedicrea International SA · 2019-05-02

Official Source

View FDA Recall →

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

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