Synthes Multi-Vector Distractor - Multi-axial Mandible Distractor (Left), Part Number 487.967. For mandibular bone lengthening.
- Company
- Synthes Usa (Hq), Inc.
- Recall Initiated
- January 11, 2013
- Posted
- March 1, 2013
- Terminated
- August 31, 2015
- Recall Number
- Z-0905-2013
- Quantity
- 18
- Firm Location
- West Chester, PA
Reason for Recall
It was discovered that the sheer pin on the Multi-Vector Distractor may not be made according to product specifications.
Distribution
Nationwide Distribution-including the states of CO, LA, MD, MN, NY, PA, RI, TN, TX and UT.
Lot / Code Info
Part number 487.967 - Lot numbers 7883454, 3808876, 7824423, 3800758, 3817116, 3794466
Root Cause
Device Design
Action Taken
The firm, Synthes (USA) sent an "URGENT NOTICE: MEDICAL DEVICE RECALL" letter dated January 11, 2013 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Contact the firmat 610-719-5450 for questions regarding this notice.
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