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Terminated

LEGION PS High Flex XLPE size 5-6 9mm Articular Insert

FDA Recall Z-1507-2020 · Posted None

Recalling FirmSmith & Nephew, Inc.
Recall StatusTerminated
Product CodeJWH
Date Initiated2019-12-19
Date Terminated2024-09-04
Product Quantity29 units

Reason for Recall

LEGION PS High Flex XLPE Articular Insert was packaged with an incorrect part

Firm Action

The firm initiated the recall by letter on January 6, 2020. The letter identified the problem and directed the consignee to quarantine the devices. The notice instructs to complete and return the response form and to make arrangement for the return of affected product. For any questions or concerns please contact: [email protected].

Root Cause

Process control

Distribution Pattern

USA: TN, NC, CA,OR, NM, TX, PA, MI, LA, DA, IL. Int'l: IT (Italy), NL (Netherlands), RO (Romania), PR (Puerto Rico).

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K071071CROSSLINKED POLYETHYLENE ARTICULAR INSERTSSmith & Nephew, Inc. · 2007-09-19

Official Source

View FDA Recall →

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

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