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Terminated

smith&nephew GENESIS(R) II TIBIAL Punch, 13 MM, REF 71440408, QTY: (1)

FDA Recall Z-2163-2018 · Posted None

Recalling FirmSmith & Nephew, Inc.
Recall StatusTerminated
Product CodeMBH
Date Initiated2018-05-04
Date Terminated2019-02-22
Product Quantity5 units

Reason for Recall

One lot of GENESIS II 13 mm tibial punches are 2 mm smaller than specification.

Firm Action

The firm initiated the recall by email on 05/04/2018. Consignees are asked to inspect inventory, locate and quarantine affected, unused devices. Affected product will be returned to Smith & Nephew. All consignees are asked to complete the Response Form, even if they do not have product to return.

Root Cause

Error in labeling

Distribution Pattern

International only: United Arab Emirates, Spain, Mexico

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K121393SMITH & NEPHEW, INC. TOTAL KNEE SYSTEM INSTRUMENTATIONSmith & Nephew, Inc. · 2012-08-07

Official Source

View FDA Recall →

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

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