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Civco, MTSR02 Shoulder Retractor with Sherpa Wrist Loops Kit with Base, Non-sterile re-usable woo...

FDA Recall #Z-0989-2015 — Class II — December 11, 2014

Recall #Z-0989-2015 Date: December 11, 2014 Classification: Class II Status: Terminated

Product Description

Civco, MTSR02 Shoulder Retractor with Sherpa Wrist Loops Kit with Base, Non-sterile re-usable wool wrist strap, REF: 20SR02SUB2, Rx Only, 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

11

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: 20SR02SUB2

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

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