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Completed

ComposiTCP 30 Interference screw D 7- L:25 mm, REF 110004605

FDA Recall Z-1361-2022 · Posted None

Recall StatusCompleted
Product CodeHWC
Date Initiated2021-10-07
Product Quantity72 units

Reason for Recall

Mislabeled product.

Firm Action

The firm notified its US distributor of the recall by email on 30 September 2021. The notice requested quarantine of the device and for the distributor to notify all interested parties with their organization and to any organization to which the device was transferred.

Root Cause

Process control

Distribution Pattern

US Nationwide distribution.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

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

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