Device product
Synthes Multi-Vector Distractor, Multi-axial Mandible Distractor (Right), Part Number 487.966. For mandibular bone lengthening.
Z-0904-2013
Product summary
- Event
- Event 64195
- Status
- Terminated
- Classification
- Class II
- Quantity
- 24
- Official record key
device-enforcement:Z-0904-2013
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 487.966 - Lot numbers 7823465, 3817114, 7806086, 3824427, 3808871, 3794465, and 7793336.
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.