CLASS II Device recall · Reported 12 Jul 2017 · FDA Enforcement Report
Medacta Gmk Hinge, Tibial Insert Fixed, Size 2, Height recalled
Medacta Usa is recalling Medacta Gmk Hinge, Tibial Insert Fixed, Size 2, Height, distributed in Arizona, California, North Carolina. The recall was initiated on 19 May 2017 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-2661-2017
- FDA event ID
- 77467
- Recalling firm
- Medacta Usa, Memphis, TN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 19 May 2017
- FDA classified
- 3 Jul 2017
- Reported
- 12 Jul 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- N/A
- Reason category
- Device Malfunction
- Device type
- Hip & Knee Implants
Timeline
| 19 May 2017 | Recall initiated by company | |
| 3 Jul 2017 | Classified by FDA | +45 days |
| 12 Jul 2017 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
One lot of product does not include a screw for attachment to the tibial base plate.
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
Medacta GMK HINGE, Tibial Insert Fixed, SIZE 2, HEIGHT 23 mm, REF 02.09.0223H, STERILE EO
Where it was distributed
CA, AZ, NC, Israel, France
Questions about this recall
Why was it recalled?
One lot of product does not include a screw for attachment to the tibial base plate.
Which lots are affected?
Lot # 163646
Where was it sold?
CA, AZ, NC, Israel, France
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.
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