Device product
Synthes Multi-Vector Distractor Body, Part Number 487.931. For mandibular bone lengthening.
Z-0903-2013
Product summary
- Event
- Event 64195
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2
- Official record key
device-enforcement:Z-0903-2013
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 487.831 - Lot numbers 7826459,7750064, 7667285, and 7806090.
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.