Device product
Synthes Multi-Vector Distractor - Multi-axial Mandible Distractor (Left), Part Number 487.967. For mandibular bone lengthening.
Z-0905-2013
Product summary
- Event
- Event 64195
- Status
- Terminated
- Classification
- Class II
- Quantity
- 18
- Official record key
device-enforcement:Z-0905-2013
Official wording
Reason: It was discovered that the sheer pin on the Multi-Vector Distractor may not be made according to product specifications.
Code information: Part number 487.967 - Lot numbers 7883454, 3808876, 7824423, 3800758, 3817116, 3794466
Distribution pattern: Nationwide Distribution-including the states of CO, LA, MD, MN, NY, PA, RI, TN, TX and UT.
Derived failure modes
-
Unknown
It was discovered that the sheer pin on the Multi-Vector Distractor may not be made according to product specifications.