CLASS II Device recall · Reported 19 Nov 2014 · FDA Enforcement Report
GMK Intramedullary Extension Rod is a rod to obtain correct recalled
Medacta Usa is recalling GMK Intramedullary Extension Rod is a rod to obtain correct leg alignment during total. The recall was initiated on 22 Sep 2014 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0202-2015
- FDA event ID
- 69493
- Recalling firm
- Medacta Usa, Chicago, IL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 22 Sep 2014
- FDA classified
- 12 Nov 2014
- Reported
- 19 Nov 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Device Malfunction
- Device type
- Hip & Knee Implants
Timeline
| 22 Sep 2014 | Recall initiated by company | |
| 12 Nov 2014 | Classified by FDA | +51 days |
| 19 Nov 2014 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
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.
Where it was distributed
Worldwide Distribution - US including OH and Internationally to Australia, Austria, Belgium, France, Germany, Greece, Italy, Japan, Portugal, South Africa, Spain, and Switzerland.
Questions about this recall
Why was it recalled?
Medacta has registered in its database 3 cases of breakage of the GMK Intramedullary Extension Rod 100 mm, code 02.07.10.0162.
Which lots are affected?
Model Number: 02.07.10.0162
Where was it sold?
Worldwide Distribution - US including OH and Internationally to Australia, Austria, Belgium, France, Germany, Greece, Italy, Japan, Portugal, South Africa, Spain, and Switzerland.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Medacta Usa
All 20| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Short Monobloc Stem Broaches, Size recalled by Medacta Usa | Medacta Usa | Device Malfunction | Nationwide |
| Device | CLASS II | MectaLIF Anterior - Lag Plate Flush H16 recalled by Medacta Usa | Medacta Usa | Device Malfunction | 5 states |
| Device | CLASS II | MectaLIF Anterior - Lag Plate Flush H12 recalled by Medacta Usa | Medacta Usa | Device Malfunction | 5 states |
| Device | CLASS II | MectaLIF Anterior - Lag Plate Flush H18 recalled by Medacta Usa | Medacta Usa | Device Malfunction | 5 states |
| Device | CLASS II | MectaLIF Anterior - Antibackout Lag Cover recalled by Medacta Usa | Medacta Usa | Device Malfunction | 5 states |
Other Hip & Knee Implants recalls
All 3,111| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Intellijoint Navigation System: Workstation G2 Configured recalled | Intellijoint Surgical | Device Malfunction | Nationwide |
| Device | CLASS II | Trinity Non-Surgical Isolation Gown, AAMI PB70 Level 2, X-Large recalled | New York Embroidery Studio | Packaging Defects | Nationwide |
| Device | CLASS II | Axle Pin Assy Large Elbow Cobalt Chrome recalled by Howmedica Osteonics | Howmedica Osteonics | Other | Nationwide |
| Device | CLASS II | Triathlon Hinge Insert Size 4 5612-p-411 Triathlon Hinge recalled | Howmedica Osteonics | Other | Nationwide |
| Device | CLASS II | Scorpio Recessed Metal Backed Patella 3045 recalled | Howmedica Osteonics | Foreign Material | Nationwide |