CLASS II Device recall · Reported 27 Dec 2017 · FDA Enforcement Report
The GMK knee system: designed for cemented use recalled by Medacta Usa
Medacta Usa is recalling The GMK knee system: designed for cemented use in total knee arthroplasty, distributed nationwide in the US. The recall was initiated on 24 Oct 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-0266-2018
- FDA event ID
- 78401
- Recalling firm
- Medacta Usa, Memphis, TN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 24 Oct 2017
- FDA classified
- 20 Dec 2017
- Reported
- 27 Dec 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Hip & Knee Implants
Timeline
| 24 Oct 2017 | Recall initiated by company | |
| 20 Dec 2017 | Classified by FDA | +57 days |
| 27 Dec 2017 | 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 observed a worldwide occurrence rate of post-operative insert screw back-out of approximately 0.1%. For this reason, we stress the importance of using the 3.5 Nm torque limiting driver if the screw is used, as directed in our surgical techniques.
Product as listed by the FDA
The GMK knee system: designed for cemented use in total knee arthroplasty. Sphere and Primary Inserts with part number ranges: 02.12.0110FL - 02.12.0620FL; 02.12.0110FR - 02.12.0620FR; 02.07.0110PSF - 02.07.0620PSF
Where it was distributed
nationwide
Questions about this recall
Is The GMK knee system: designed for cemented use in total knee arthroplasty recalled?
Yes. Medacta Usa recalled The GMK knee system: designed for cemented use in total knee arthroplasty on 24 Oct 2017. The recall is Class II and its status is Terminated. Recall number Z-0266-2018.
Why was it recalled?
Medacta has observed a worldwide occurrence rate of post-operative insert screw back-out of approximately 0.1%. For this reason, we stress the importance of using the 3.5 Nm torque limiting driver if the screw is used, as directed in our surgical techniques.
Which lots are affected?
all serial numbers
Where was it sold?
nationwide
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 21 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 17| 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 3,097| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline convenience kits labeled as: Femoral Pack, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Arvis Surgical Navigation System Gen recalled by Kico Knee Innovation | Kico Knee Innovation | Nitrosamine Impurity | 19 states |
| Device | CLASS II | Veritas Standard Reverse Total Shoulder Veritas Standard recalled | restor3d | Device Malfunction | Nationwide |
| Device | CLASS II | Endo-Model, Replacement Set, Tibial Plateau, right/left, L, Uhmwpe recalled | Waldemar Link GmbH & Co. KG (Mfg Site) | Lead & Heavy Metals | IN |
| Device | CLASS II | U2 Total Knee System Femoral offset bushing recalled | United Orthopedic | Device Malfunction | Nationwide |