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Terminated

Corin MetaFix Hip Stem, Size 1, Short Neck, 135 degrees, Collared Hip Stem, REF 579.0201, Sterile.

FDA Recall Z-2609-2021 · Posted None

Recalling FirmCorin Ltd
Recall StatusTerminated
Product CodeMEH
Date Initiated2021-07-28
Date Terminated2024-06-12
Product Quantity2 units

Reason for Recall

The packaging system on the devices have potential physical and water damage resulting in damage to the devices, loss of sterility, or contamination of the devices.

Firm Action

On 7/28&29/2021, the firm sent emails entitled "IMPORTANT-containment request FA COUK 2021 013" which notified the consignee they have been identified as receiving one or more of the medical devices listed in the attached Excel file due to them potentially having physical and/or water damage. They were to quarantine the parts until further instructions were issued. On 9/7/2021, Corin USA issued recall letters dated 9/3/2021 via email on 9/7/2021 requesting the devices be quarantined and returned.

Root Cause

Storage

Distribution Pattern

US Nationwide distribution in the states of AZ, CA, FL, IL, OK, PA, TX, UT, and WI.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K082525CORIN METAFIX FEMORAL STEMCorin USA · 2010-02-04

Official Source

View FDA Recall →

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

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