Civco, MTSR03 Shoulder Retractor with Wrist Loops Kit with Base, plus two pairs of wrist loops (n...
FDA Recall #Z-0990-2015 — Class II — December 11, 2014
Product Description
Civco, MTSR03 Shoulder Retractor with Wrist Loops Kit with Base, plus two pairs of wrist loops (nylon and sherpa), Non-sterile re-usable wool wrist strap, REF: 20SR03, Rx The devise is intended to pull patients shoulders down for clearance when treating lateral fields to the neck.
Reason for Recall
The product (wool wrist loop) was manufactured 7cm shorter than product specifications.
Recalling Firm
Med Tec Inc — Orange City, IA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
2
Distribution
Worldwide Distribution - US Distribution to the states of : AZ, MO, PA and WI., and the countries of : Austria, India and Japan.
Code Information
Lot: M612690 REF: 20SR03
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated