Skip to content
Recall Observatory FDA recall evidence

Device product

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.

Z-0989-2015

December 11, 2014

Class II

Product summary

Firm
Med Tec Inc
Event
Event 69997
Status
Terminated
Classification
Class II
Quantity
11
Official record key
device-enforcement:Z-0989-2015

Official wording

Reason: The product (wool wrist loop) was manufactured 7cm shorter than product specifications.

Code information: Lot: M612690 REF: 20SR02SUB2

Distribution pattern: Worldwide Distribution - US Distribution to the states of : AZ, MO, PA and WI., and the countries of : Austria, India and Japan.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The product (wool wrist loop) was manufactured 7cm shorter than product specifications.