Medacta GMK HINGE, Tibial Insert Fixed, SIZE 2, HEIGHT 23 mm, REF 02.09.0223H, STERILE EO
FDA Recall Z-2661-2017 · Posted 2017-06-12
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Recalling FirmMedacta Usa Inc
Recall StatusTerminated
Product CodeKRO
Date Initiated2017-05-19
Date Terminated2018-05-29
Product Quantity4 units
Reason for Recall
One lot of product does not include a screw for attachment to the tibial base
plate.
Firm Action
On 5/19/17 all distributors with recalled product were immediately notified of the recall by email. On 5/23/17, all distributors were further notified of the recall via phone. On 5/30/17, a third notification was completed via phone.
Root Cause
Nonconforming Material/Component
Distribution Pattern
CA, AZ, NC, Israel, France
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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