Medacta MectaLIF Oblique Handle Recalled for Incorrect Laser Marking
Medacta USA is recalling 32 MectaLIF Oblique Handles because incorrect laser markings could lead to improper device insertion during surgery.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a surgical instrument where a defect could lead to incorrect device insertion during surgery, representing a risk of harm where injury has not yet been reported.
Plain-English summary
Medacta USA is recalling 32 units of the MectaLIF Oblique Handle, model number 03.22.10.0262, lot number 1314256. The product is a surgical instrument used to insert MectaLIF oblique spinal cage implants.
The recall was initiated because the handles have the laser marking "MEDIAL" on the incorrect side. This defect could result in the incorrect insertion of the device during surgery. The affected units were distributed worldwide, including in the United States (California, Colorado, and Idaho) and internationally to Australia and Germany.
Healthcare providers and patients should contact Medacta USA for further instructions regarding the return or replacement of these specific handles.
The recalled product
- Product
- The MectaLIF Oblique Handle, model number 03.22.10.0262, is used to insert the MectaLIF oblique spinal cage implants.
- Manufacturer
- Medacta Usa
- Affected units
- 32
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Model Number: 03.22.10.0262
- Lot Number: 1314256
Distribution
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