Z-0990-2015 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- January 21, 2015
- Initiation Date
- December 11, 2014
- Termination Date
- February 3, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2
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.
Distribution Pattern
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