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Terminated

GMK Intramedullary Extension Rod 100 mm is a rod to obtain correct leg alignment during total knee replacement. Rod to obtain correct leg alignment during total knee replacement.

FDA Recall Z-0202-2015 · Posted 2014-11-12

Recalling FirmMedacta Usa
Recall StatusTerminated
Product CodeHSB
Date Initiated2014-09-22
Date Terminated2015-05-07
Product Quantity1 rod (US); 145 rods (global)

Reason for Recall

Medacta has registered in its database 3 cases of breakage of the GMK Intramedullary Extension Rod 100 mm, code 02.07.10.0162.

Firm Action

Medacta sent an URGENT MEDICAL DEVICE letter dated September 22, 2014 to the sole US consignee. The letter included instructions for the consignee to: 1) check its inventory of the device; 2) quarantine and do not use the recalled device; and, 3) return the recalled device upon receipt of a RMA # from the Medacta QA Department. For questions regarding this recall call 805-910-6511.

Root Cause

Nonconforming Material/Component

Distribution Pattern

Worldwide Distribution - US including OH and Internationally to Australia, Austria, Belgium, France, Germany, Greece, Italy, Japan, Portugal, South Africa, Spain, and Switzerland.

Official Source

View FDA Recall →

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

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