CLASS II Device recall · Reported 26 Nov 2014 · FDA Enforcement Report
The MectaLIF Oblique Handle recalled by Medacta U
Medacta Usa is recalling The MectaLIF Oblique Handle, distributed in California, Colorado, Idaho. The recall was initiated on 21 Oct 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-0225-2015
- FDA event ID
- 69693
- Recalling firm
- Medacta Usa, Chicago, IL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 21 Oct 2014
- FDA classified
- 18 Nov 2014
- Reported
- 26 Nov 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Other Reasons
- Device type
- Spinal Implants
Timeline
| 21 Oct 2014 | Recall initiated by company | |
| 18 Nov 2014 | Classified by FDA | +28 days |
| 26 Nov 2014 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The MectaLIF Oblique Handle has the laser marking "MEDIAL" on the incorrect side and could result in incorrect insertion of the device during surgery.
Product as listed by the FDA
The MectaLIF Oblique Handle, model number 03.22.10.0262, is used to insert the MectaLIF oblique spinal cage implants.
Where it was distributed
Worldwide Distribution - US including CA, CO, ID and Internationally to Australia and Germany.
Questions about this recall
Why was it recalled?
The MectaLIF Oblique Handle has the laser marking "MEDIAL" on the incorrect side and could result in incorrect insertion of the device during surgery.
Which lots are affected?
Model Number: 03.22.10.0262; Lot Number: 1314256
Where was it sold?
Worldwide Distribution - US including CA, CO, ID and Internationally to Australia and Germany.
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 Spinal Implants recalls
All 1,159| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Extended Polyaxial Head, Attached Gimbal recalled | Seaspine Orthopedics | Other | Nationwide |
| Device | CLASS II | Medline Convenience Kits: Anterior Spine Pack recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Neuro; Neuro; Crani; Ortho Spine Pack; Bmhm Neuro Pack recalled | Avid Medical | Sterility | Nationwide |
| Device | CLASS II | Halyard medical convenience kits labeled as: ENT recalled | Avid Medical | Sterility | Nationwide |
| Device | CLASS II | Halyard medical convenience kits labeled as: A-P PACK recalled | Avid Medical | Sterility | Nationwide |