FDA Medical Device Recalls (openFDA)
Medacta Usa: 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.
- Recall number
- Z-0202-2015
- Recalling firm
- Medacta Usa
- Product
- 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.
- Status
- Terminated
- Initiated
- 2014-09-22
- Posted
- 2014-11-12
- Terminated
- 2015-05-07
- Reason
- Medacta has registered in its database 3 cases of breakage of the GMK Intramedullary Extension Rod 100 mm, code 02.07.10.0162.
- Root cause
- Nonconforming Material/Component
- 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.
- Quantity
- 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.
- Lot, serial or model codes
- Model Number: 02.07.10.0162
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- HSB
- Firm FEI
- 3015500078
- Firm city
- Chicago
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28