GMK Intramedullary Extension Rod 100 mm is a rod to obtain correct leg alignment during total knee replacement. Rod to o
FDA device recall Z-0202-2015 · posted 2014-11-12 · Terminated
Recall details
- Recalling firm
- Medacta Usa
- 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.
- Action taken
- 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
- Status
- Terminated
- Product code
- HSB
- Quantity affected
- 1 rod (US); 145 rods (global)
- Distribution
- Worldwide Distribution - US including OH and Internationally to Australia, Austria, Belgium, France, Germany, Greece, Italy, Japan, Portugal, South Africa, Spain, and Switzerland.
- Date initiated
- 2014-09-22
- Date posted
- 2014-11-12
- Date terminated
- 2015-05-07
- Location
- Chicago, IL
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